Early Post Transplant Cardiac Allograft Vasculopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Post Transplant Cardiac Allograft Vasculopathy

Conditions
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Cardiac Allograft Vasculopathy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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