Early Post Transplant Cardiac Allograft Vasculopathy

Cardiac Allograft Vasculopathy Clinical Trial

— ECAV  

Official title:

Early Post Transplant Cardiac Allograft Vasculopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03217786
• Other study ID #: 0868
• Status: Active, not recruiting
• Start date: February 12, 2018
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Allograft Vasculopathy
• Vascular Diseases

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Toronto General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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