RecruitingNot ApplicableNCT06089486

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

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


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

576 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria8

  • 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.

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Interventions

DIAGNOSTIC_TESTICA

Patients will undergo annual CAV surveillance with ICA

DIAGNOSTIC_TESTPET

Patients will undergo annual CAV surveillance with PET


Locations(5)

University of Calgary

Calgary, Alberta, Canada

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Toronto-General Hospital - University Health Network

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

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NCT06089486


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