MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation

University of Ottawa Heart Institute

Status: Enrolling

Conditions: Cardiac Allograft Vasculopathy

Treatments: Diagnostic Test: ICA; Diagnostic Test: PET

Study type: Interventional

Funder types: Other

Identifiers

NCT06089486

20230460-01T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 576 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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576 participants in 2 patient groups

Invasive Coronary Angiography

Other group

Description:

Patients in this arm will undergo annual CAV surveillance with ICA

Treatment:

Diagnostic Test: ICA

Positron Emission Tomography

Other group

Description:

Patients in this arm will undergo annual CAV surveillance with PET

Treatment:

Diagnostic Test: PET