MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Invasive Coronary Angiography Patients in this arm will undergo annual CAV surveillance with ICA |
Diagnostic Test: ICA
Patients will undergo annual CAV surveillance with ICA
|
| Other: Positron Emission Tomography Patients in this arm will undergo annual CAV surveillance with PET |
Diagnostic Test: PET
Patients will undergo annual CAV surveillance with PET
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Post heart transplant 2-10 years.
-
Age ≥18 years.
-
Able to provide informed consent.
Exclusion Criteria:
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Contraindication to dipyridamole due to severe aortic stenosis.
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Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
-
Contraindication to dipyridamole due to severe bronchospasm.
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Unable to undergo coronary angiography due to allergy to iodinated contrast.
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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.
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Unable to undergo coronary angiography due to unsuitable vascular access.
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Treated rejection ≤1-month.
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Unstable angina or MI ≤7 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Calgary | Calgary | Alberta | Canada | |
| 2 | Mazankowski Alberta Heart Institute | Edmonton | Alberta | Canada | |
| 3 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
| 4 | Toronto-General Hospital - University Health Network | Toronto | Ontario | Canada | |
| 5 | Montreal Heart Institute | Montreal | Quebec | Canada |
Sponsors and Collaborators
- Ottawa Heart Institute Research Corporation
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Sharon Chih, Ottawa Heart Institute Research Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230460-01T