Trial Outcomes & Findings for Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD (NCT NCT02326649)
NCT ID: NCT02326649
Last Updated: 2017-04-12
Results Overview
Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml
Recruitment status
COMPLETED
Target enrollment
21 participants
Primary outcome timeframe
2 hours
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
SMIC and CMR
Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diagnosis, Age, and Body Size of Subjects
n=21 Participants
Overall
|
|---|---|
|
Age, Continuous
|
18 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=21 Participants
|
|
Body Surface Area
|
1.67 meters squared
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hoursMean difference in stroke volume (SV) between CMR and SMIC measurements in ml
Outcome measures
| Measure |
SMIC and CMR
n=21 Participants
Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
|
|---|---|
|
Mean Difference in Stroke Volume Between CMR and SMIC
|
1.7 ml
Interval -3.1 to 6.6
|
Adverse Events
CHD Patients Undergoing Cardiac MRI Without Sedation
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