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Recruiting NCT06089486

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

No phase Interventional Cardiac Allograft Vasculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICA, PET.
Who it may be relevant to
Registry conditions: Cardiac Allograft Vasculopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test ICA
    Patients will undergo annual CAV surveillance with ICA
  • Diagnostic test PET
    Patients will undergo annual CAV surveillance with PET

Primary outcome measures

  • Clinically relevant composite: Death [Time frame: 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]
  • Clinically relevant composite: Allograft Dysfunction [Time frame: 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]
Secondary outcome measures (5)
  • Rate of new or progressive CAV [Time frame: 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 procedural related complications (ICA and PET) [Time frame: 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]
  • Health Resource Utilization [Time frame: From date of randomization up to a minimum of 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Canada · 5 centers
  • University of Calgary — Calgary
  • Mazankowski Alberta Heart Institute — Edmonton
  • University of Ottawa Heart Institute — Ottawa
  • Toronto-General Hospital - University Health Network — Toronto
  • Montreal Heart Institute — Montreal

Identifiers

NCT: NCT06089486 · 20230460-01T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗