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NCT Number: NCT06089486

MARINER Trial: Multiparametric Cardiac PET for CAV 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.

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Key information

Conditions

Cardiac Allograft Vasculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post heart transplant 2-10 years.
  • Age ≥18 years.
  • Able to provide informed consent.

Exclusion criteria

  • Contraindication to dipyridamole due to severe aortic stenosis.
  • Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
  • Contraindication to dipyridamole due to severe bronchospasm.
  • Unable to undergo coronary angiography due to allergy to iodinated contrast.
  • 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.
  • Unable to undergo coronary angiography due to unsuitable vascular access.
  • Treated rejection ≤1-month.
  • Unstable angina or MI ≤7 days.

Treatment and study plan

ICA

Diagnostic Test

Patients will undergo annual CAV surveillance with ICA

PET

Diagnostic Test

Patients will undergo annual CAV surveillance with PET

Primary outcomes

  1. Clinically relevant composite: Death

    Time frame: From date of randomization up to a minimum of 2 years

    Date of death due to any cause

  2. Clinically relevant composite: Retransplant

    Time frame: From date of randomization up to a minimum of 2 years

    Heart retransplantation for any indication

  3. 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

  4. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Ross

CONTACT

[email protected]

Sharon Chih

CONTACT

[email protected]

613-696-7000

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Oct 18, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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