Early Post Transplant Cardiac Allograft Vasculopathy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03217786

Acronym

ECAV

Enrollment

Registered

2017-07-14

Start date

2018-02-12

Completion date

2026-12-01

Last updated

2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Allograft Vasculopathy

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
CAV on invasive coronary studies	3 months and 1-year post-transplant.	Changes in coronary intima on IVUS and OCT and invasive coronary flow

Secondary

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

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORSharon Chih, MD, PhD

Ottawa Heart Institute Research Corporation

Outcome results