Clinical trial NCT03217786: Early Post Transplant Cardiac Allograft Vasculopathy
Official title: Early Post Transplant Cardiac Allograft Vasculopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Toronto General Hospital
First posted: 2017-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CAV on invasive coronary studies
timeFrame: 3 months and 1-year post-transplant.
Secondary outcomes:
measure: EMBx
timeFrame: 3 months post-transplant
measure: PET
timeFrame: 3 months post-transplant
measure: Biomarkers
timeFrame: 3 months post-transplant
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Sharon Chih, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: