NCT06089486 MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
| NCT ID | NCT06089486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Cardiac Allograft Vasculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 576 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 576 participants in total. It began in 2024-01-08 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Sharon Chih
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06089486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Allograft Vasculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06089486 currently recruiting?
Yes, NCT06089486 is actively recruiting participants. Contact the research team at schih@ottawaheart.ca for enrollment information.
Where is the NCT06089486 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Ottawa, Canada, Toronto, Canada and 1 additional location.
Who is sponsoring the NCT06089486 clinical trial?
NCT06089486 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Sharon Chih at Ottawa Heart Institute Research Corporation. The trial plans to enroll 576 participants.