Recruiting

Cardiac PET

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06089486

Conditions

Cardiac Allograft Vasculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ICA

PET

Study Details

Brief 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. 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.

Conditions

Cardiac Allograft Vasculopathy

Study ID

NCT06089486

Start date

Jan 8, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

576 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Invasive Coronary Angiography

Patients in this arm will undergo annual CAV surveillance with ICA

other: Positron Emission Tomography

Patients in this arm will undergo annual CAV surveillance with PET

Interventions

ICA

Patients will undergo annual CAV surveillance with ICA

PET

Patients will undergo annual CAV surveillance with PET

Primary outcome measure

  • Clinically relevant composite: Death [ Time Frame: From date of randomization up to a minimum of 2 years ]
  • Clinically relevant composite: Retransplant [ Time Frame: From date of randomization up to a minimum of 2 years ]
  • Clinically relevant composite: Allograft Dysfunction [ Time Frame: From date of randomization up to a minimum of 2 years ]
  • Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction [ Time Frame: From date of randomization up to a minimum of 2 years ]

Central Contacts and Locations

Central contacts

Sharon Chih

613-696-7000schih@ottawaheart.ca

Heather Ross

heather.ross@uhn.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Heart Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-06.