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

Not Applicable

Recruiting

• Conditions: Cardiac Allograft Vasculopathy
• Interventions: Diagnostic Test: ICA; Diagnostic Test: PET

• Registration Number: NCT06089486
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2024-01-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03
• Primary Completion: 2028-10
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 576

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive Coronary Angiography	ICA	Patients in this arm will undergo annual CAV surveillance with ICA
Positron Emission Tomography	PET	Patients in this arm will undergo annual CAV surveillance with PET

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Health Resource Utilization	From date of randomization up to a minimum of 2 years	Cost effectiveness of each CAV surveillance strategy (ICA and PET)
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)

Trial Locations

Locations (5)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Toronto-General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada

Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada