Trial Outcomes & Findings for Cardiovascular Complications of Sickle Cell Disease (NCT NCT01044901)
NCT ID: NCT01044901
Last Updated: 2022-02-23
Results Overview
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Recruitment status
COMPLETED
Target enrollment
51 participants
Primary outcome timeframe
Parameter measured at baseline.
Results posted on
2022-02-23
Participant Flow
Participant milestones
| Measure |
Subjects With Sickle Cell Disease (SCD)
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
13
|
|
Overall Study
COMPLETED
|
38
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular Complications of Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
32 years
n=99 Participants
|
25 years
n=107 Participants
|
29 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Surface Area
|
2.0 m^2
n=99 Participants
|
1.8 m^2
n=107 Participants
|
2.0 m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - LVEDVi, mL/cm2 (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
124.0 mL/cm2
Standard Deviation 26.8
|
78.7 mL/cm2
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - LVESVi, mL/cm2 - (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
47 mL/cm2
Interval 39.0 to 62.0
|
31 mL/cm2
Interval 24.0 to 37.0
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - LV Mass Index, g/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
77.2 g/cm2
Standard Deviation 19.2
|
51.6 g/cm2
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - RVEDVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
126.4 mL/cm2
Standard Deviation 27.7
|
83.0 mL/cm2
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - RVESVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
56.3 mL/cm2
Standard Deviation 17.1
|
37.8 mL/cm2
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - LAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
64.8 mL/cm2
Standard Deviation 16.2
|
41.1 mL/cm2
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - RAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
76 mL/cm2
Interval 66.0 to 86.0
|
52 mL/cm2
Interval 48.0 to 56.0
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - LVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
58 percentage of ejection fraction
Interval 55.0 to 62.0
|
64 percentage of ejection fraction
Interval 56.0 to 67.0
|
PRIMARY outcome
Timeframe: Parameter at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - RVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
|
56.1 percentage of ejection fraction
Standard Deviation 6.4
|
55.4 percentage of ejection fraction
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Population: Some parameters were unable to be collected from patients with Sickle Cell Disease.
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=32 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Late Gadolinium Enhancement, Performed Via Visual Inspection, Normally None Should be Present
|
8 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Myocardial T2-star, ms, Performed Using Decay Curves (Normal >20ms)
|
41.6 ms
Standard Deviation 13.4
|
38.4 ms
Standard Deviation 14.4
|
PRIMARY outcome
Timeframe: Parameter at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Hepatic T2-star, ms, Performed Using Decay Curves, Normal >18ms
|
10 ms
Interval 5.0 to 27.0
|
30 ms
Interval 24.0 to 38.0
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Myocardial Perfusion Reserve Index, Measured Using Upslope Technique. Control Subjects Available for Normal Ranges
|
1.4 index
Standard Deviation 0.3
|
1.87 index
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Population: The measure was unable to be measured for some patients with Sickle Cell Disease.
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=35 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Diastolic Dysfunction, Determined According to American Society of Echocardiography Guidelines
|
10 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Lateral E/e', Measured Using Doppler Echo. Controls Available as Normal Ranges
|
7.2 ratio
Interval 5.9 to 9.8
|
6.0 ratio
Interval 5.1 to 6.7
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Augmentation Pressure, See Controls for Normal Ranges
|
9.0 percentage of the pulse pressure
Interval 4.5 to 16.8
|
2.0 percentage of the pulse pressure
Interval 0.3 to 14.1
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Augmentation Index, See Control Subjects for Normal Ranges
|
23.6 index
Standard Deviation 16.2
|
12.5 index
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
|
MRI Parameter - Systemic Systolic Blood Pressure
|
122.3 mmHg
Standard Deviation 21.7
|
132 mmHg
Standard Deviation 17.6
|
PRIMARY outcome
Timeframe: Parameter measured at baseline.Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
Outcome measures
| Measure |
Subjects With Sickle Cell Disease (SCD)
n=38 Participants
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
Healthy Volunteers
n=13 Participants
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
MRI, Transthoracic Echocardiography, tonometry, EKG: Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
|
|---|---|---|
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MRI Parameter - Systemic Diastolic Blood Pressure, mm Hg
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68.3 mmHg
Standard Deviation 18.1
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74.9 mmHg
Standard Deviation 16.3
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SECONDARY outcome
Timeframe: median follow up 3 yearsPopulation: All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.
To detect genome-wide gene expression and targeted genetic polymorphisms in SCD patients linked to a quantitative noninvasive-based PH phenotype.
Outcome measures
Outcome data not reported
Adverse Events
Subjects With Sickle Cell Disease (SCD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place