Trial Outcomes & Findings for Comprehensive Evaluation of Ischemic Heart Disease Using MRI (NCT NCT01234870)
NCT ID: NCT01234870
Last Updated: 2014-09-26
Results Overview
The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
COMPLETED
PHASE2/PHASE3
40 participants
Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.
2014-09-26
Participant Flow
Participant milestones
| Measure |
Ischemic Heart Disease Patients
Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Baseline characteristics by cohort
| Measure |
Adenosine
n=40 Participants
Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins
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|---|---|
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Age, Continuous
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60.9 years
STANDARD_DEVIATION 8.21 • n=99 Participants
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Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
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Region of Enrollment
United States
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40 participants
n=99 Participants
|
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Body Mass Index (BMI)
|
29.57 kg/m^2
STANDARD_DEVIATION 5.83 • n=99 Participants
|
PRIMARY outcome
Timeframe: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
Outcome measures
| Measure |
Ischemic Heart Disease Patients
n=40 Participants
Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
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|---|---|
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Magnetic Resonance Image Quality Rating
Motion Corrected Images
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3.57 units on a likert scale
Standard Deviation 0.66
|
|
Magnetic Resonance Image Quality Rating
Non-Corrected Breath-Hold, Shallow-Breathing Image
|
2.55 units on a likert scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 14 daysAdverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.
Outcome measures
| Measure |
Ischemic Heart Disease Patients
n=40 Participants
Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
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|---|---|
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Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
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0 occurances of adverse events
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Adverse Events
Adenosine
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