Early Post Transplant Cardiac Allograft Vasculopathy (ECAV)

March 6, 2024 updated by: Ottawa Heart Institute Research Corporation
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months and 1-year post-transplant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMBx
Time Frame: 3 months post-transplant
Microvascular disease
3 months post-transplant
PET
Time Frame: 3 months post-transplant
Myocardial blood flow quantification
3 months post-transplant
Biomarkers
Time Frame: 3 months post-transplant
Serum biomarker panel
3 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Toronto General Hospital

Investigators

  • Principal Investigator: Sharon Chih, MD, PhD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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