Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Xie Mingxing
- Enrollment
- 1,500
- Primary Endpoint
- Using Image-Pro Plus 6.0 software to measure myocardial fibrosis
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy volunteers
Exclusion Criteria
- •had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography
Outcomes
Primary Outcomes
Using Image-Pro Plus 6.0 software to measure myocardial fibrosis
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Major adverse cardiac events after the inclusion of the study(Major adverse cardiac events happened after inclusion of this study，up to 5 years)
Investigators
Xie Mingxing
Department of Ultrasound, Union Hospital
Wuhan Union Hospital, China