CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Perflutren Lipid Microsphere +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02880137
NCT02880137Phase 4Completed
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(RTMPE for CAV) Real Time Myocardial Perfusion Echocardiography for Detection of Coronary Allograft Vasculopathy in Cardiac Transplant Patients

Mayo Clinic·interventional·Posted Aug 26, 2016·Updated Jun 20, 2019

In Brief

A Phase 4 clinical trial evaluating Perflutren Lipid Microsphere and RTMPE for Cardiac Allograft Vasculopathy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and adult cardiac transplant recipients? Will perfusion deficits correlate with significant coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary Angiography (ICA), and identify diffuse small vessel disease more effectively than current non-invasive techniques?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Allograft Vasculopathy
CountriesUnited States
CollaboratorsUniversity of Calgary

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 26, 2016
Enrollment StartSep 1, 2016
Primary CompletionJun 1, 2018
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago

Interventions

Perflutren Lipid Microspheredrug

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.

RTMPEprocedure

Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.