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Heart transplant patients may soon skip invasive artery checks with new PET scan study

NCT ID NCT06089486

Diagnosis Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-invasive PET scan can safely replace the standard invasive coronary angiography for monitoring heart transplant patients. About 576 participants who had a heart transplant 2-10 years ago will be randomly assigned to annual surveillance with either PET or angiography. The goal is to see if PET is just as good at detecting dangerous artery narrowing without the risks of an invasive procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If PET proves as effective as invasive angiography, heart transplant patients could avoid repeated invasive procedures for routine monitoring.
What could go wrong
This is a non-inferiority trial, so PET might not be as accurate as angiography. The study is observational in design, not testing a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Post heart transplant 2-10 years. 2. Age ≥18 years. 3. Able to provide informed consent. Exclusion Criteria: 1. Contraindication to dipyridamole due to severe aortic stenosis. 2. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker. 3. Contraindication to dipyridamole due to severe bronchospasm. 4. Unable to undergo coronary angiography due to allergy to iodinated contrast. 5. 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. 6. Unable to undergo coronary angiography due to unsuitable vascular access. 7. Treated rejection ≤1-month. 8. Unstable angina or MI ≤7 days.

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Conditions

The condition(s) this trial relates to.

chronic transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac allograft vasculopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mazankowski Alberta Heart Institute

    NOT_YET_RECRUITING

    Edmonton, Alberta, Canada

  • Montreal Heart Institute

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • Toronto-General Hospital - University Health Network

    NOT_YET_RECRUITING

    Toronto, Ontario, Canada

  • University of Calgary

    NOT_YET_RECRUITING

    Calgary, Alberta, Canada

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

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