Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Transplant Failure and Rejection
- Sponsor
- Semmelweis University Heart and Vascular Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Coronary allograft vasculopathy
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.
Detailed Description
1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations. 2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed. 3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality. 4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers. 5. Endomyocardial biopsy 6. Detailed transthoracic echocardiography including strain analysis and 3D measurement 7. Detailed cardiac magnetic resonance (CMR) examination 8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) 9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)
Investigators
Hajnalka Vágó MD PhD
MD PhD, Associate Professor
Semmelweis University Heart and Vascular Center
Eligibility Criteria
Inclusion Criteria
- •First heart transplantation
Exclusion Criteria
- •Cardiogenic shock on/after day 28 after heart transplantation
- •Lack of consent
- •Lack of cooperation
Outcomes
Primary Outcomes
Coronary allograft vasculopathy
Time Frame: 5 years
Coronary allograft vasculopathy confirmed based on IVUS/OCT
Coronary allograft rejection
Time Frame: 5 years
Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters