Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03217786

Early Post Transplant Cardiac Allograft Vasculopathy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Allograft Vasculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. CAV on invasive coronary studies

    Time frame: 3 months and 1-year post-transplant.

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

Secondary outcomes

  1. EMBx

    Time frame: 3 months post-transplant

    Microvascular disease

  2. PET

    Time frame: 3 months post-transplant

    Myocardial blood flow quantification

  3. Biomarkers

    Time frame: 3 months post-transplant

    Serum biomarker panel

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Toronto General Hospital

Registry information

Acronym: ECAV

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Jul 14, 2017
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.