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

ConditionCardiac Allograft Vasculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Post heart transplant 2-10 years.

Age ≥18 years.

Able to provide informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICA

    Diagnostic test

    Patients will undergo annual CAV surveillance with ICA

  • PET

    Diagnostic test

    Patients will undergo annual CAV surveillance with PET

Treatment groups

576 Participants
are divided into 2 treatment groups
Group A: Invasive Coronary AngiographyOther 1 intervention
Group B: Positron Emission TomographyOther 1 intervention

Trial outcomes

Primary outcomes

1

Clinically relevant composite: Death

Date of death due to any cause

Time frame
From date of randomization up to a minimum of 2 years
2

Clinically relevant composite: Retransplant

Heart retransplantation for any indication

Time frame
From date of randomization up to a minimum of 2 years
3

Clinically relevant composite: Allograft Dysfunction

≥25% decrease in left ventricular ejection fraction

Time frame
From date of randomization up to a minimum of 2 years
4

Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction

Angiographic evidence of CAV (ISHLT CAV 1-3)

Time frame
From date of randomization up to a minimum of 2 years

Secondary outcomes

1

Rate of new or progressive CAV

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
2

Number of ICA performed

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
3

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

Time frame
From date of randomization up to a minimum of 2 years
4

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)

Time frame
Baseline and 12-monthly up to a minimum of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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