Clinical trial NCT06089486: MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Official title: Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Allograft Vasculopathy
Keywords: Heart Transplant
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-10-18
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to PET or ICA
Primary purpose: SCREENING

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.

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.

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.

Primary outcomes:
measure: Clinically relevant composite: Death
timeFrame: From date of randomization up to a minimum of 2 years
measure: Clinically relevant composite: Retransplant
timeFrame: From date of randomization up to a minimum of 2 years
measure: Clinically relevant composite: Allograft Dysfunction
timeFrame: From date of randomization up to a minimum of 2 years
measure: Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
timeFrame: From date of randomization up to a minimum of 2 years
Secondary outcomes:
measure: Rate of new or progressive CAV
timeFrame: From date of randomization up to a minimum of 2 years
measure: Number of ICA performed
timeFrame: From date of randomization up to a minimum of 2 years
measure: Number of procedural related complications (ICA and PET)
timeFrame: From date of randomization up to a minimum of 2 years
measure: Patient Health related outcomes
timeFrame: Baseline and 12-monthly up to a minimum of 2 years
measure: Health Resource Utilization
timeFrame: From date of randomization up to a minimum of 2 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto-General Hospital - University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Sharon Chih
role: PRINCIPAL_INVESTIGATOR
References: