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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089486
Other study ID # 20230460-01T
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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