Head to Head Comparison of Multidetector Coronary Tomography and Conventional Coronary Angiogram in the Setting of Systematic Screening of Coronary Vasculopathy After Orthotopic Heart Transplantation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- sensitivity of CT : Frequency of stenosis diagnosed by CT in comparison with frequency of stenosis diagnosed by coronarography
Study Overview
Brief Summary
Coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation. It is mainly asymptomatic because of the denervation of the heart transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of coronary narrowing. But invasive coronary angiography caries risks of serious adverse events and some concern rise from its repetition in that population. Recent advance in coronary multidetector computed tomography (CT) may allow non invasive visualization of the coronary tree. But, it remains unknown if the encouraging data observed in native coronary artery analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample size studies (20 patients) have been conducted in this particular setting. Thus, the investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT compared to the gold standard coronary angiogram in a larger sample size study. The practice aim of this study is to determine if the conventional invasive coronarography can be switched by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous coronary intervention.
Detailed Description
Background:
Heart transplantation is a major advance in the care of patient with terminal heart failure. But, despite the spectacular prognosis improvement obtained with this treatment, coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation (8% of death at 1 year, 42% at 5 years). This coronary artery disease (CAD) has a particular feature involving immunological and inflammatory process, also favoured by classical risk factors in the context of immunosuppression, with rapid and diffuse involvement. Because of the denervation of the transplant heart, it remains mainly asymptomatic and let non invasive stress tests with poor accuracy for CAD screening. It explains the current use of systematic coronary angiogram to transplant heart recipient's survey.
But coronary angiogram remains an invasive technique and exposed to potential serious adverse events.
The recent advance in coronary multidetector computed tomography (CT) may allow non invasive visualization of the coronary tree. Indeed, 64-row CT has already showed its accuracy for the screening of CAD in symptomatic patient in sinus rhythm. However, they are very few studies in the setting of heart transplantation with small sample size and mainly using 16-row CT. Only two small sample size studies (20 patients each) have been conducted using 64-row CT in the setting of heart transplant recipients. None of them compared X-Ray and contrast iodine exposure.
Aim :
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Transplant heart patients
- •Years > 18
- •Informed Content
Exclusion Criteria
- •< 18 years old
- •Renal failure (Creatinine > 150 µmol/l)
- •Patient in complete arrhythmia due to auricular fibrillation
- •Patient with a Cardiac Basic frequency > 100 / min
- •Iodine Allergy
- •Patient hospitalized except the frame of the annual systematic monitoring
- •Pregnancy
- •People unable to sign the informed content such as major under supervision
- •Patients non affiliated to the social security system
Outcomes
Primary Outcomes
sensitivity of CT : Frequency of stenosis diagnosed by CT in comparison with frequency of stenosis diagnosed by coronarography
Time Frame: Day 1
Secondary Outcomes
- specificity, positive predictive value, negative predictive value of CT(Day 1)
- X-Ray and contrast agent exposure(Day 1)