Comparing ICA with PET for cardiac allograft vasculopathy
Official title: MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
- 2 groups
- Sites in Calgary, Edmonton and 3 more cities
- Recruiting
Interventions
- Other intervention
ICA
Patients will undergo annual CAV surveillance with ICA
- Other intervention
PET
Patients will undergo annual CAV surveillance with PET
Canadian Sites (5)
1 of 5 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Not yet recruiting
University of Calgary
Calgary, Alberta
- Not yet recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta
- Not yet recruiting
Toronto-General Hospital - University Health Network
Toronto, Ontario
- Not yet recruiting
Montreal Heart Institute
Montreal, Quebec
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Post heart transplant 2-10 years.
- +Age ≥18 years.
- +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Unable to undergo coronary angiography due to allergy to iodinated contrast.
- −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 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to detect a condition before symptoms appear.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives ICA.
Registry label: A: Invasive Coronary Angiography
Group B receives PET.
Registry label: B: Positron Emission Tomography
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 576 people.
The study is currently expected to finish around March 2029.
The main measurement is taken over: From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to a minimum of 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Clinically relevant composite: Death — measured over From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to a minimum of 2 years.
Clinically relevant composite: Retransplant — measured over From date of randomization up to a minimum of 2 years.
Clinically relevant composite: Allograft Dysfunction — measured over From date of randomization up to a minimum of 2 years.
Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction — measured over From date of randomization up to a minimum of 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06089486 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ICADiagnostic test
Patients will undergo annual CAV surveillance with ICA
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
About PETDiagnostic test
Patients will undergo annual CAV surveillance with PET
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to a minimum of 2 years.
The study as a whole is currently expected to finish around 2029-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 576 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.