Phase 4
N=36
Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT02880137 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Subjects With a Perfusion Defect — 5; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Perflutren Lipid Microsphere (Drug); RTMPE (Procedure)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Perfusion Defect |
5; 6 | — |
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?
Eligibility Criteria
Inclusion:
- Cardiac transplant recipients (> or equal to 10 months post transplant)
- Clinically followed at Mayo Clinic, Rochester Minnesota
Exclusion:
- Standard contraindications to the use of ultrasound contrast and pharmacologic stress
- Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
- Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
- Hypersensitivity to perflutren
Data sourced from ClinicalTrials.gov (NCT02880137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.