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

Cardiac Allograft Vasculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089486
• Other study ID #: 20230460-01T
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: March 2029

Study information

• Verified date: January 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Sharon Chih
• Phone: 613-696-7000
• Email: schih[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: March 2029
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Allograft Vasculopathy
• Vascular Diseases

Intervention

Diagnostic Test:
• ICA
Patients will undergo annual CAV surveillance with ICA
• PET
Patients will undergo annual CAV surveillance with PET

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Toronto-General Hospital - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically relevant composite: Death	Date of death due to any cause	From date of randomization up to a minimum of 2 years
Primary	Clinically relevant composite: Retransplant	Heart retransplantation for any indication	From date of randomization up to a minimum of 2 years
Primary	Clinically relevant composite: Allograft Dysfunction	=25% decrease in left ventricular ejection fraction	From date of randomization up to a minimum of 2 years
Primary	Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction	Angiographic evidence of CAV (ISHLT CAV 1-3)	From date of randomization up to a minimum of 2 years
Secondary	Rate of new or progressive CAV	CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS	From date of randomization up to a minimum of 2 years
Secondary	Number of ICA performed	Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication	From date of randomization up to a minimum of 2 years
Secondary	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	From date of randomization up to a minimum of 2 years
Secondary	Patient 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)	Baseline and 12-monthly up to a minimum of 2 years
Secondary	Health Resource Utilization	Cost effectiveness of each CAV surveillance strategy (ICA and PET)	From date of randomization up to a minimum of 2 years