Overview
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.
Description
MARINER is a Canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive PET strategy compared to ICA for CAV surveillance. Patients are randomized to annual PET or ICA for CAV surveillance. Non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic CAV associated with myocardial infarction or heart failure. Secondary outcomes include the rate of new or progressive CAV, number of ICA performed, number of ICA and PET procedural related complications, EuroQol-5 Dimension assessed patient health-related quality of life and health care resource use.
Eligibility
Inclusion Criteria:
- Post heart transplant 2-10 years.
- Age ≥18 years.
- Able to provide informed consent.
Exclusion Criteria:
- Contraindication to dipyridamole due to severe aortic stenosis.
- Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
- Contraindication to dipyridamole due to severe bronchospasm.
- Unable to undergo coronary angiography due to allergy to iodinated contrast.
- 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.
- Unable to undergo coronary angiography due to unsuitable vascular access.
- Treated rejection ≤1-month.
- Unstable angina or MI ≤7 days.