Heart Transplantation Clinical Trial
Official title:
Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy
Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated
thickening of the heart arteries of transplanted hearts. CAV limits the long term survival
of heart transplant patients and is one of the common causes of death in the late post
transplant period. Current methods of detecting CAV rest with invasive cardiac
catheterization which carry repeated risks, as this test needs to be performed periodically
through the life of a heart transplant patient. Traditional methods of coronary angiography
identify CAV late in its course and is a crude method of evaluating coronary anatomy in
heart transplant patients. Intravascular ultrasound is an additive tool that is able to
detect early CAV before it becomes angiographically apparent, but still requires invasive
cardiac catheterization to perform. However, it also limits assessment to the major
epicardial arteries and does not give any information regarding the smaller branch vessels
and cardiac microvasculature. Advances in cardiac CT and cardiac MRI hold potential to
evaluate for CAV non-invasively. In addition, perfusion techniques may provide additional
functional information regarding the status of the microvascular.
In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI
with and without perfusion protocols, in patients post-heart transplant and to describe and
compare CT and MRI findings in patients with established CAV versus those with no CAV, as
diagnosed by standard invasive methods.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2023 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years of age - Greater than or equal to 12 months post transplant - Able to undergo cardiac CT and cardiac MRI Exclusion Criteria: - Creatinine clearance less than or equal to 45ml/min per 1.73m2) - Severe aortic stenosis - Long-QT syndrome (corrected QT >440ms) - AV block grade II/III - Sick sinus syndrome - New York Heart Association heart failure class III/IV - Chronic obstructive pulmonary disease - Asthma - Atrial fibrillation - Left ventricular ejection fraction <50% - Presence of a pacemaker or ICD - Presence of any metal in body |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Science Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events from cardiac CT and cardiac MRI scan in heart transplant patients | Testing the safety and feasibility of performing cardiac CT and MRI with perfusion protocols in heart transplant patients. Adverse events: serum creatinine increase >25% from baseline within 1 week, drop in systolic blood pressure >30mmHg, arrhythmias, chest pain, shortness of breath during drug infusion for perfusion protocols, inability to reduce heart rate <80bpm for cardiac CT. | Day 1 | No |
Secondary | Describe CT and MRI imaging findings of established CAV | Day 1 | No | |
Secondary | Correlation between intimal thickening by IVUS imaging at cardiac catheterization and CCT and CMR perfusion abnormalities | Day 1 | No | |
Secondary | The association between CCT/CMR perfusion abnormalities one year post transplant and the development of angiographically apparent CAV, graft dysfunction, cardiac adverse events, and overall survival long term | 10 years | No |
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