ECAV: Early Post Transplant Cardiac Allograft Vasculopathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- EMBx [3 months post-transplant]
Microvascular disease
- PET [3 months post-transplant]
Myocardial blood flow quantification
- Biomarkers [3 months post-transplant]
Serum biomarker panel
Eligibility Criteria
Criteria
Inclusion Criteria:
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Heart transplant <3 months.
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Age ≥18 years.
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Able and willing to provide informed consent.
Exclusion Criteria:
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Contraindications to dipyridamole.
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Contraindications to aminophylline.
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Contraindications to nitroglycerin.
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Contraindications to iodinated contrast.
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Acute allograft rejection ≤1 month.
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Uncontrolled heart failure or myocardial infarction ≤7 days.
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Estimated glomerular filtration rate ≤30 mL/min.
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Combined solid organ transplantation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y4W7 |
Sponsors and Collaborators
- Ottawa Heart Institute Research Corporation
- Toronto General Hospital
Investigators
- Principal Investigator: Sharon Chih, MD, PhD, Ottawa Heart Institute Research Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0868