Trials / Recruiting
RecruitingNCT06089486
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 576 (estimated)
- Sponsor
- Ottawa Heart Institute Research Corporation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ICA | Patients will undergo annual CAV surveillance with ICA |
| DIAGNOSTIC_TEST | PET | Patients will undergo annual CAV surveillance with PET |
Timeline
- Start date
- 2024-01-08
- Primary completion
- 2028-10-01
- Completion
- 2029-03-01
- First posted
- 2023-10-18
- Last updated
- 2025-04-03
Locations
5 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT06089486. Inclusion in this directory is not an endorsement.