Trial Outcomes & Findings for Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy (NCT NCT02880137)
NCT ID: NCT02880137
Last Updated: 2019-06-20
Results Overview
A perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
baseline
Results posted on
2019-06-20
Participant Flow
Participant milestones
| Measure |
RTMPE
RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for cardiac allograft vasculopathy (CAV) detection.
Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.
RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
RTMPE
n=36 Participants
RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.
Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.
RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
|
|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: baselineA perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).
Outcome measures
| Measure |
RTMPE
n=36 Participants
RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.
Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.
RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
|
|---|---|
|
Number of Subjects With a Perfusion Defect
Perfusion defect identified by ICA
|
5 Participants
|
|
Number of Subjects With a Perfusion Defect
Perfusion defect identified by RTMPE
|
6 Participants
|
Adverse Events
RTMPE
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