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

Primary Purpose

Cardiac Allograft Vasculopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ICA
PET
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cardiac Allograft Vasculopathy focused on measuring Heart Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Post heart transplant 2-10 years. Age ≥18 years. Able to provide informed consent. Exclusion Criteria: Contraindication to dipyridamole due to severe aortic stenosis. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker. Contraindication to dipyridamole due to severe bronchospasm. Unable to undergo coronary angiography due to allergy to iodinated contrast. 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. Unable to undergo coronary angiography due to unsuitable vascular access. Treated rejection ≤1-month. Unstable angina or MI ≤7 days.

Sites / Locations

  • University of Calgary
  • Mazankowski Alberta Heart Institute
  • University of Ottawa Heart Institute
  • Toronto-General Hospital - University Health Network
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Invasive Coronary Angiography

Positron Emission Tomography

Arm Description

Patients in this arm will undergo annual CAV surveillance with ICA

Patients in this arm will undergo annual CAV surveillance with PET

Outcomes

Primary Outcome Measures

Clinically relevant composite: Death
Date of death due to any cause
Clinically relevant composite: Retransplant
Heart retransplantation for any indication
Clinically relevant composite: Allograft Dysfunction
≥25% decrease in left ventricular ejection fraction
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
Angiographic evidence of CAV (ISHLT CAV 1-3)

Secondary Outcome Measures

Rate of new or progressive CAV
CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS
Number of ICA performed
Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication
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
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)
Health Resource Utilization
Cost effectiveness of each CAV surveillance strategy (ICA and PET)

Full Information

First Posted
September 29, 2023
Last Updated
October 12, 2023
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT06089486
Brief Title
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Official Title
Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2028 (Anticipated)
Study Completion Date
March 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Allograft Vasculopathy
Keywords
Heart Transplant

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to PET or ICA
Masking
None (Open Label)
Allocation
Randomized
Enrollment
576 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Invasive Coronary Angiography
Arm Type
Other
Arm Description
Patients in this arm will undergo annual CAV surveillance with ICA
Arm Title
Positron Emission Tomography
Arm Type
Other
Arm Description
Patients in this arm will undergo annual CAV surveillance with PET
Intervention Type
Diagnostic Test
Intervention Name(s)
ICA
Intervention Description
Patients will undergo annual CAV surveillance with ICA
Intervention Type
Diagnostic Test
Intervention Name(s)
PET
Intervention Description
Patients will undergo annual CAV surveillance with PET
Primary Outcome Measure Information:
Title
Clinically relevant composite: Death
Description
Date of death due to any cause
Time Frame
From date of randomization up to a minimum of 2 years
Title
Clinically relevant composite: Retransplant
Description
Heart retransplantation for any indication
Time Frame
From date of randomization up to a minimum of 2 years
Title
Clinically relevant composite: Allograft Dysfunction
Description
≥25% decrease in left ventricular ejection fraction
Time Frame
From date of randomization up to a minimum of 2 years
Title
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
Description
Angiographic evidence of CAV (ISHLT CAV 1-3)
Time Frame
From date of randomization up to a minimum of 2 years
Secondary Outcome Measure Information:
Title
Rate of new or progressive CAV
Description
CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS
Time Frame
From date of randomization up to a minimum of 2 years
Title
Number of ICA performed
Description
Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication
Time Frame
From date of randomization up to a minimum of 2 years
Title
Number of procedural related complications (ICA and PET)
Description
The frequency of ICA and PET procedural related complication including vascular access complications, stroke, MI, arrhythmia, drug allergy and contrast nephropathy
Time Frame
From date of randomization up to a minimum of 2 years
Title
Patient Health related outcomes
Description
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)
Time Frame
Baseline and 12-monthly up to a minimum of 2 years
Title
Health Resource Utilization
Description
Cost effectiveness of each CAV surveillance strategy (ICA and PET)
Time Frame
From date of randomization up to a minimum of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post heart transplant 2-10 years. Age ≥18 years. Able to provide informed consent. Exclusion Criteria: Contraindication to dipyridamole due to severe aortic stenosis. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker. Contraindication to dipyridamole due to severe bronchospasm. Unable to undergo coronary angiography due to allergy to iodinated contrast. 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. Unable to undergo coronary angiography due to unsuitable vascular access. Treated rejection ≤1-month. Unstable angina or MI ≤7 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Chih
Phone
613-696-7000
Email
schih@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Ross
Email
heather.ross@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Chih
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Miller
Facility Name
Mazankowski Alberta Heart Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Kim
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Chih
Facility Name
Toronto-General Hospital - University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Ross
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tremblay-Gravel

12. IPD Sharing Statement

Learn more about this trial

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

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