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PET Imaging for Cardiac Vasculopathy After Heart Transplant

N/A

Recruiting

Led By Sharon Chih

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization up to a minimum of 2 years

Awards & highlights

Study Summary

This trial will assess whether PET is as effective as ICA in monitoring heart transplant patients for narrowing of the heart arteries, a condition known as CAV.

Who is the study for?

The MARINER trial is for adults over 18 who had a heart transplant between 2-10 years ago and can give informed consent. It's not for those with severe heart valve issues, certain heart rhythm problems without a pacemaker, bad kidney function, severe asthma-like conditions, allergies to iodine contrast used in scans, poor vein access for procedures, recent treated rejection or unstable angina/heart attack.Check my eligibility

What is being tested?

This study compares two ways of checking for narrowed arteries in the heart after a transplant: PET scans (a non-invasive imaging test) and ICA (an invasive procedure). The aim is to see if PET can be as good as ICA at monitoring patients without needing an invasive procedure.See study design

What are the potential side effects?

Potential side effects from the dipyridamole used in PET might include headache, dizziness or chest pain. For ICA, risks may involve bleeding where the catheter was inserted, allergic reactions to dye used during angiography or more rarely heart attack or stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization up to a minimum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization up to a minimum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to a minimum of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinically relevant composite: Allograft Dysfunction

Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction

Clinically relevant composite: Death

+1 more

Secondary outcome measures

Health Resource Utilization

Number of ICA performed

Number of procedural related complications (ICA and PET)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Positron Emission TomographyExperimental Treatment1 Intervention

Patients in this arm will undergo annual CAV surveillance with PET

Group II: Invasive Coronary AngiographyExperimental Treatment1 Intervention

Patients in this arm will undergo annual CAV surveillance with ICA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET

2009

Completed Phase 4

~700

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor

188 Previous Clinical Trials

91,860 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,452,938 Total Patients Enrolled

Sharon ChihPrincipal InvestigatorOttawa Heart Institute Research Corporation

1 Previous Clinical Trials

135 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

On how many sites is this trial currently being administered?

"Participants of this study can be found in several medical centres, including the Mazankowski Alberta Heart Institute (Edmonton), University of Ottawa Heart Institute (Ottawa) and Toronto-General Hospital - University Health Network (Toronto). In addition, there are 5 additional research sites."

Answered by AI

Is enrollment open for this experiment?

"According to the data on clinicaltrials.gov, this particular medical trial is no longer accepting candidates. Initially posted on October 1st 2023 and edited most recently on October 12th 2023, it appears that recruitment has closed; however, there are currently 120 other clinical trials actively searching for participants."

Answered by AI

What aims does this trial hope to accomplish?

"The two year medical trial's primary aim is to examine the clinical efficacy of retransplantation. Secondary outcomes being assessed include the number of ICA procedures, procedural related complications resulting from both ICA and PET scans, as well as patient health-related results based on a EuroQol survey measuring five domains with best state marked at 100 and worst state recorded at 0."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06089486.