MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantatio
Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasiv
| Condition(s) | Cardiac Allograft Vasculopathy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance. |
| Who can participate | Inclusion Criteria: 1. Post heart transplant 2-10 years. 2. Age ≥18 years. 3. Able to provide informed consent. Exclusion Criteria: 1. Contraindication to dipyridamole due to severe aortic stenosis. 2. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker. 3. Contraindication to dipyridamole due to severe bronchospasm. 4. Unable to undergo coronary angiography due to allergy to iodinated contrast. 5. Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2. for non-dialysis patients as determined by local laboratory analysis. 6. Unable to undergo coronary angiography due to unsuitable vascular access. 7. Treated rejection ≤1-month. 8. Unstable angina or MI ≤7 days. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ottawa Heart Institute Research Corporation |
| Locations | Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada |
| Start date | 2024-01-08 |
| NCT ID | NCT06089486 |
| Official listing | https://clinicaltrials.gov/study/NCT06089486 |