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Cardiac Allograft VasculopathyECAVNCT03217786

Early Post Transplant Cardiac Allograft Vasculopathy

An observational study of Cardiac Allograft Vasculopathy, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Allograft Vasculopathy
How many people
80 participants
Where
1 siteCanada
Study dates
12 Feb 2018to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

Other trials in Canada

About this study

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.

Read the detailed description

The objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of CAV. We will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. Heart transplant patients from the University of Ottawa Heart Institute and Toronto General Hospital will undergo a series of tests at 3 and 12 months after transplant. Statistical analyses will determine whether results from the above tests at 3 months predict the development of early CAV at 12 months after a heart transplant.

Keywords
Macrovascular Disease, Microvascular Coronary Artery Disease, Cardiac Transplant Rejection, Transplant; Failure, Heart, Intravascular ultrasound (IVUS), Optical Coherence Tomography, Index of Microcirculatory Resistance, Fractional Flow Reserve, Coronary Flow Reserve, Positron Emission Tomography, Endomyocardial Biopsies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CAV on invasive coronary studies

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

    Measured: 3 months and 1-year post-transplant.

Secondary outcomes (3)

  1. EMBx

    Microvascular disease

    Measured: 3 months post-transplant

  2. PET

    Myocardial blood flow quantification

    Measured: 3 months post-transplant

  3. Biomarkers

    Serum biomarker panel

    Measured: 3 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2017
  2. Study start12 Feb 2018
  3. Primary completion31 Mar 2023
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217786
Sponsor's protocol ID
0868
Acronym
ECAV
Status last verified
Apr 2026
First submitted
11 Jul 2017
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37999656

  • 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.

    PubMed 37165901

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Allograft Vasculopathy, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CAV on invasive coronary studies (time frame: 3 months and 1-year post-transplant.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03217786, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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