Heart TIMING - Heart Transplantation IMagING
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|ClinicalTrials.gov Identifier: NCT03499197|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment|
|Heart Transplant Failure and Rejection Magnetic Resonance Imaging||Diagnostic Test: cardiac magnetic resonance imaging|
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
- Endomyocardial biopsy
- Detailed transthoracic echocardiography including strain analysis and 3D measurement
- Detailed cardiac magnetic resonance (CMR) examination
- Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
- Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||January 15, 2026|
- Diagnostic Test: cardiac magnetic resonance imaging
Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499197
|Contact: Hajnalka Vago, MD, PhD||+3620 firstname.lastname@example.org|
|Heart and Vascular Center, Semmelweis University||Recruiting|
|Contact: Hajnalka Vago, MD, PhD|