Cardiac Allograft VasculopathyNCT06089486
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
A study testing ICA and PET in people with Cardiac Allograft Vasculopathy, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- What is being tested?
- ICA and PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 5 sitesCanada
- Study dates
- 8 Jan 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post heart transplant 2-10 years.
- Age ≥18 years.
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Heather Ross contact
5 sites in 1 country
Canada5 sites, 5 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta
Robert Miller
- Not yet recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta
Daniel Kim
- Not yet recruiting
Montreal Heart Institute
Montreal, Quebec
Tremblay-Gravel
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Sharon Chih
- Not yet recruiting
Toronto-General Hospital - University Health Network
Toronto, Ontario
Heather Ross
About this study
Official title: Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
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.
Read the 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.
- Conditions
- Cardiac Allograft Vasculopathy
- Being tested
- ICA, PET
- Keywords
- Heart Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICADiagnostic test
Patients will undergo annual CAV surveillance with ICA
PETDiagnostic test
Patients will undergo annual CAV surveillance with PET
| Study group | Role | What they receive |
|---|---|---|
| Invasive Coronary Angiography | Other | Patients in this arm will undergo annual CAV surveillance with ICA Receives: Diagnostic Test: ICA |
| Positron Emission Tomography | Other | Patients in this arm will undergo annual CAV surveillance with PET Receives: Diagnostic Test: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically relevant composite: Death
Date of death due to any cause
Measured: From date of randomization up to a minimum of 2 years
Clinically relevant composite: Retransplant
Heart retransplantation for any indication
Measured: From date of randomization up to a minimum of 2 years
Clinically relevant composite: Allograft Dysfunction
≥25% decrease in left ventricular ejection fraction
Measured: From date of randomization up to a minimum of 2 years
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction
Angiographic evidence of CAV (ISHLT CAV 1-3)
Measured: From date of randomization up to a minimum of 2 years
Secondary outcomes (5)
Rate of new or progressive CAV
CAV disease severity according to ISHLT CAV 0-3 grading and/or MIT on IVUS
Measured: From date of randomization up to a minimum of 2 years
Number of ICA performed
Number of ICA performed for any indication including CAV surveillance, abnormal PET or clinical indication
Measured: From date of randomization up to a minimum of 2 years
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
Measured: From date of randomization up to a minimum of 2 years
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)
Measured: Baseline and 12-monthly up to a minimum of 2 years
Health Resource Utilization
Cost effectiveness of each CAV surveillance strategy (ICA and PET)
Measured: From date of randomization up to a minimum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start8 Jan 2024
- Primary completionOct 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to PET or ICA
- Masking
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Sharon Chih, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089486
- Sponsor's protocol ID
- 20230460-01T
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
- ClinicalTrials.gov ID
- NCT06089486
- Acronym / sponsor ID
- 20230460-01T
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Heart Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to PET or ICA
| Arm | Type | Receives |
|---|---|---|
| Invasive Coronary Angiography | Other | Diagnostic Test: ICAPatients in this arm will undergo annual CAV surveillance with ICA |
| Positron Emission Tomography | Other | Diagnostic Test: PETPatients in this arm will undergo annual CAV surveillance with PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post heart transplant 2-10 years.
- Age ≥18 years.
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICAPatients will undergo annual CAV surveillance with ICA | Diagnostic test | Invasive Coronary Angiography |
| PETPatients will undergo annual CAV surveillance with PET | Diagnostic test | Positron Emission Tomography |
Primary outcome
Clinically relevant composite: Death
Time frame: From date of randomization up to a minimum of 2 years
Date of death due to any cause
Clinically relevant composite: Retransplant
Time frame: From date of randomization up to a minimum of 2 years
Heart retransplantation for any indication
Clinically relevant composite: Allograft Dysfunction
Time frame: 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
Time frame: From date of randomization up to a minimum of 2 years
Angiographic evidence of CAV (ISHLT CAV 1-3)
5 secondary outcomes
Rate of new or progressive CAV
Time frame: From date of randomization up to a minimum of 2 years
Number of ICA performed
Time frame: From date of randomization up to a minimum of 2 years
Number of procedural related complications (ICA and PET)
Time frame: From date of randomization up to a minimum of 2 years
Patient Health related outcomes
Time frame: Baseline and 12-monthly up to a minimum of 2 years
Health Resource Utilization
Time frame: From date of randomization up to a minimum of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Ross contact
Sharon Chih principal investigator
Ottawa Heart Institute Research Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICA and PET in people with Cardiac Allograft Vasculopathy, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Chih (613-696-7000, schih@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically relevant composite: Death (time frame: From date of randomization up to a minimum of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.