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.
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
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
576
University of Calgary
Calgary, Alberta, Canada
NOT_YET_RECRUITINGMazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
NOT_YET_RECRUITINGUniversity of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGClinically relevant composite: Death
Date of death due to any cause
Time frame: From date of randomization up to a minimum of 2 years
Clinically relevant composite: Retransplant
Heart retransplantation for any indication
Time frame: From date of randomization up to a minimum of 2 years
Clinically relevant composite: Allograft Dysfunction
≥25% decrease in left ventricular ejection fraction
Time frame: From date of randomization up to a minimum of 2 years
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
Angiographic evidence of CAV (ISHLT CAV 1-3)
Time frame: From date of randomization up to a minimum of 2 years
Rate of new or progressive CAV
CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS
Time frame: From date of randomization up to a minimum of 2 years
Number of ICA performed
Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication
Time frame: From date of randomization up to a minimum of 2 years
Number of procedural related complications (ICA and PET)
The frequency of ICA and PET procedural related complication including vascular access complications, stroke, MI, arrhythmia, drug allergy and contrast nephropathy
Time frame: From date of randomization up to a minimum of 2 years
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Toronto-General Hospital - University Health Network
Toronto, Ontario, Canada
NOT_YET_RECRUITINGMontreal Heart Institute
Montreal, Quebec, Canada
NOT_YET_RECRUITINGPatient Health related outcomes
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)
Time frame: Baseline and 12-monthly up to a minimum of 2 years
Health Resource Utilization
Cost effectiveness of each CAV surveillance strategy (ICA and PET)
Time frame: From date of randomization up to a minimum of 2 years