Using PET scans to monitor heart transplant patients for complications
Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
This study is testing if regular PET scans can safely monitor heart transplant patients for complications instead of the usual invasive procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 576 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Trial ID | NCT06089486 on ClinicalTrials.gov |
What this trial studies
The MARINER trial evaluates the effectiveness of noninvasive positron emission tomography (PET) for monitoring cardiac allograft vasculopathy (CAV) in heart transplant patients compared to traditional invasive coronary angiography (ICA). This multicenter, randomized trial will assess whether PET is non-inferior to ICA in terms of patient outcomes, including death, retransplantation, and graft dysfunction. Participants will be randomly assigned to receive either annual PET scans or ICA for surveillance, with various secondary outcomes also being measured, such as quality of life and healthcare resource use.
Who should consider this trial
Good fit: Ideal candidates are heart transplant recipients aged 18 years or older who are between 2 to 10 years post-transplant.
Not a fit: Patients with severe aortic stenosis, significant AV block, or other contraindications to dipyridamole or coronary angiography will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer, noninvasive method for monitoring heart transplant patients, potentially improving patient outcomes and quality of life.
How similar studies have performed: Other studies have explored noninvasive imaging techniques for cardiac monitoring, but this specific approach comparing PET to ICA is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Calgary, Alberta and 4 other locations
- University of Calgary — Calgary, Alberta, Canada (Not_yet_recruiting)
- Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada (Not_yet_recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- Toronto-General Hospital - University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Sharon Chih — Ottawa Heart Institute Research Corporation
- Study coordinator: Sharon Chih
- Email: schih@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.