Cardiac Allograft Vasculopathy
Conditions
Keywords
Heart Transplant
Brief 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.
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_TESTICA
Patients will undergo annual CAV surveillance with ICA
DIAGNOSTIC_TESTPET
Patients will undergo annual CAV surveillance with PET
Sponsors
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
1:1 randomization to PET or ICA
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant composite: Death | From date of randomization up to a minimum of 2 years | Date of death due to any cause |
| Clinically relevant composite: Retransplant | From date of randomization up to a minimum of 2 years | Heart retransplantation for any indication |
| Clinically relevant composite: Allograft Dysfunction | From date of randomization up to a minimum of 2 years | ≥25% decrease in left ventricular ejection fraction |
| Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction | From date of randomization up to a minimum of 2 years | Angiographic evidence of CAV (ISHLT CAV 1-3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of new or progressive CAV | 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 |
| Number of ICA performed | 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 |
| Number of procedural related complications (ICA and PET) | 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 |
| Patient Health related outcomes | 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) |
| Health Resource Utilization | From date of randomization up to a minimum of 2 years | Cost effectiveness of each CAV surveillance strategy (ICA and PET) |
Countries
Canada
Contacts
CONTACTSharon Chih
CONTACTHeather Ross
PRINCIPAL_INVESTIGATORSharon Chih
Ottawa Heart Institute Research Corporation
Outcome results
None listed