A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation
- Conditions
- Heart Transplant
- Registration Number
- NCT04974372
- Lead Sponsor
- Xie Mingxing
- Brief Summary
The aims of this study are to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection (AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.
- Detailed Description
This study will enrolled 1000 HT patients and 500 healthy controls, and the cardiac structure and function will be evaluated by ultrasound multimodal imaging. And the study aimed to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection(AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- healthy volunteers
- had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Using Image-Pro Plus 6.0 software to measure myocardial fibrosis the measurement of myocardial fibrosis up to 1 year after heart transplant The extent of myocardial fibrosis of the myocardial tissue from the removed heart during heart transplant was measured by Image-Pro Plus 6.0 software up to 1 year after heart transplant
All cause death after the inclusion of the study All cause death happened after inclusion of this study, up to 5 years All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records every year
Acute rejection after the inclusion of the study Acute rejection happened after inclusion of this study, up to 5 years Acute rejection after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year
Cardiac allograft vasculopathy after the inclusion of the study Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years Cardiac allograft vasculopathy after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year
- Secondary Outcome Measures
Name Time Method Major adverse cardiac events after the inclusion of the study Major adverse cardiac events happened after inclusion of this study，up to 5 years Major adverse cardiac events after the inclusion of the study was obtained at regular intervals via telephone interview with the patient, or if deceased, with family members; contact with his/her physicians; or hospital records every year