Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02880137|
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Allograft Vasculopathy||Drug: Perflutren Lipid Microsphere Procedure: RTMPE||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||(RTMPE for CAV) Real Time Myocardial Perfusion Echocardiography for Detection of Coronary Allograft Vasculopathy in Cardiac Transplant Patients|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 30, 2018|
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.
Drug: 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.
Other Name: Definity
Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Other Name: Real Time Myocardial Perfusion Echocardiography
- Number of Subjects With a Perfusion Defect [ Time Frame: baseline ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880137
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jonathan N Johnson, MD||Mayo Clinic|