NCT03217786

Brief Summary

Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. CAV is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. Early detection of CAV is important as treatment options are poor once the disease is established. Currently, available techniques to evaluate CAV are limited by poor ability to detect disease early. The current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress94%
Feb 2018Dec 2026

First Submitted

Initial submission to the registry

July 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

July 11, 2017

Last Update Submit

April 29, 2026

Conditions

Cardiac Allograft Vasculopathy

Keywords

Macrovascular DiseaseMicrovascular Coronary Artery DiseaseCardiac Transplant RejectionTransplant; Failure, HeartIntravascular ultrasound (IVUS)Optical Coherence TomographyIndex of Microcirculatory ResistanceFractional Flow ReserveCoronary Flow ReservePositron Emission TomographyEndomyocardial Biopsies

Outcome Measures

Primary Outcomes (1)

  • CAV on invasive coronary studies

    Changes in coronary intima on IVUS and OCT and invasive coronary flow

    3 months and 1-year post-transplant.

Secondary Outcomes (3)

  • EMBx

    3 months post-transplant

  • PET

    3 months post-transplant

  • Biomarkers

    3 months post-transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective longitudinal study will involve 2 Canadian adult heart transplant programs: University of Ottawa Heart Institute (UOHI, Ottawa) and University Health Network-Toronto General Hospital (UHN-TGH, Toronto).

You may qualify if:

  • Heart transplant \<3 months.
  • Age ≥18 years.
  • Able and willing to provide informed consent.

You may not qualify if:

  • Contraindications to dipyridamole.
  • Contraindications to aminophylline.
  • Contraindications to nitroglycerin.
  • Contraindications to iodinated contrast.
  • Acute allograft rejection ≤1 month.
  • Uncontrolled heart failure or myocardial infarction ≤7 days.
  • Estimated glomerular filtration rate ≤30 mL/min.
  • Combined solid organ transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (2)

  • Chih S, Tavoosi A, Nair V, Chong AY, Dzavik V, Aleksova N, So DY, deKemp RA, Amara I, Wells GA, Bernick J, Overgaard CB, Celiker-Guler E, Mielniczuk LM, Stadnick E, McGuinty C, Ross HJ, Beanlands RSB. Cardiac PET Myocardial Blood Flow Quantification Assessment of Early Cardiac Allograft Vasculopathy. JACC Cardiovasc Imaging. 2024 Jun;17(6):642-655. doi: 10.1016/j.jcmg.2023.10.003. Epub 2023 Nov 22.

    PMID: 37999656DERIVED

  • Chih S, Chong AY, Dzavik V, So DY, Aleksova N, Wells GA, Bernick J, Overgaard CB, Stadnick E, Mielniczuk LM, Beanlands RSB, Ross HJ. Fibrotic Plaque and Microvascular Dysfunction Predict Early Cardiac Allograft Vasculopathy Progression After Heart Transplantation: The Early Post Transplant Cardiac Allograft Vasculopathy Study. Circ Heart Fail. 2023 Jun;16(6):e010173. doi: 10.1161/CIRCHEARTFAILURE.122.010173. Epub 2023 May 11.

    PMID: 37165901DERIVED

Biospecimen

Specimens will be assessed for potential CAV biomarkers.

Study Officials

  • Sharon Chih, MD, PhD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 14, 2017

Study Start

February 12, 2018

Primary Completion

March 31, 2023

Study Completion (Estimated)

December 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

CA(1)