NCT06089486

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jan 2024Mar 2029

First Submitted

Initial submission to the registry

September 29, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

September 29, 2023

Last Update Submit

April 29, 2026

Conditions

Cardiac Allograft Vasculopathy

Keywords

Heart Transplant

Outcome Measures

Primary Outcomes (4)

  • Clinically relevant composite: Death

    Date of death due to any cause

    From date of randomization up to a minimum of 2 years

  • Clinically relevant composite: Retransplant

    Heart retransplantation for any indication

    From date of randomization up to a minimum of 2 years

  • Clinically relevant composite: Allograft Dysfunction

    ≥25% decrease in left ventricular ejection fraction

    From date of randomization up to a minimum of 2 years

  • Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction

    Angiographic evidence of CAV (ISHLT CAV 1-3)

    From date of randomization up to a minimum of 2 years

Secondary Outcomes (5)

  • Rate of new or progressive CAV

    From date of randomization up to a minimum of 2 years

  • Number of ICA performed

    From date of randomization up to a minimum of 2 years

  • Number of procedural related complications (ICA and PET)

    From date of randomization up to a minimum of 2 years

  • Patient Health related outcomes

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

  • Health Resource Utilization

    From date of randomization up to a minimum of 2 years

Study Arms (2)

Invasive Coronary Angiography

OTHER

Patients in this arm will undergo annual CAV surveillance with ICA

Diagnostic Test: ICA

Positron Emission Tomography

OTHER

Patients in this arm will undergo annual CAV surveillance with PET

Diagnostic Test: PET

Interventions

ICADIAGNOSTIC_TEST

Patients will undergo annual CAV surveillance with ICA

Invasive Coronary Angiography
PETDIAGNOSTIC_TEST

Patients will undergo annual CAV surveillance with PET

Positron Emission Tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post heart transplant 2-10 years.
  • Age ≥18 years.
  • Able to provide informed consent.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Calgary

Calgary, Alberta, Canada

NOT YET RECRUITING

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Toronto-General Hospital - University Health Network

Toronto, Ontario, Canada

NOT YET RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

NOT YET RECRUITING

Study Officials

  • Sharon Chih

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Chih

CONTACT

613-696-7000schih@ottawaheart.ca

Heather Ross

CONTACT

heather.ross@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 1:1 randomization to PET or ICA
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 18, 2023

Study Start

January 8, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

CA(5)