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

April 29, 2026 updated by: Ottawa Heart Institute Research Corporation

Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

576

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Not yet recruiting
        • University of Calgary
        • Contact:
          • Robert Miller
      • Edmonton, Alberta, Canada
        • Not yet recruiting
        • Mazankowski Alberta Heart Institute
        • Contact:
          • Daniel Kim
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
          • Sharon Chih
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Toronto-General Hospital - University Health Network
        • Contact:
          • Heather Ross
    • Quebec
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • Montreal Heart Institute
        • Contact:
          • Tremblay-Gravel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Invasive Coronary Angiography
Patients in this arm will undergo annual CAV surveillance with ICA
Diagnostic test: ICA
Patients will undergo annual CAV surveillance with ICA
Other: Positron Emission Tomography
Patients in this arm will undergo annual CAV surveillance with PET
Diagnostic test: PET
Patients will undergo annual CAV surveillance with PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically relevant composite: Death
Time Frame: From date of randomization up to a minimum of 2 years
Date of death due to any cause
From date of randomization up to a minimum of 2 years
Clinically relevant composite: Retransplant
Time Frame: From date of randomization up to a minimum of 2 years
Heart retransplantation for any indication
From date of randomization up to a minimum of 2 years
Clinically relevant composite: Allograft Dysfunction
Time Frame: From date of randomization up to a minimum of 2 years
≥25% decrease in left ventricular ejection fraction
From date of randomization up to a minimum of 2 years
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
Time Frame: From date of randomization up to a minimum of 2 years
Angiographic evidence of CAV (ISHLT CAV 1-3)
From date of randomization up to a minimum of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of new or progressive CAV
Time Frame: From date of randomization up to a minimum of 2 years
CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS
From date of randomization up to a minimum of 2 years
Number of ICA performed
Time Frame: From date of randomization up to a minimum of 2 years
Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication
From date of randomization up to a minimum of 2 years
Number of procedural related complications (ICA and PET)
Time Frame: From date of randomization up to a minimum of 2 years
The frequency of ICA and PET procedural related complication including vascular access complications, stroke, MI, arrhythmia, drug allergy and contrast nephropathy
From date of randomization up to a minimum of 2 years
Patient Health related outcomes
Time Frame: Baseline and 12-monthly up to a minimum of 2 years
EuroQol-5 Dimension is a standardized health related questionnaire measuring 5 domains of health and a state of health using a visual analog scale (best state marked 100 and worst state marked 0)
Baseline and 12-monthly up to a minimum of 2 years
Health Resource Utilization
Time Frame: From date of randomization up to a minimum of 2 years
Cost effectiveness of each CAV surveillance strategy (ICA and PET)
From date of randomization up to a minimum of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Sharon Chih, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230460-01T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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