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临床试验/NCT04974372
NCT04974372尚未招募不适用

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Xie Mingxing0 个研究点目标入组 1,500 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
主要终点
Using Image-Pro Plus 6.0 software to measure myocardial fibrosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers

排除标准

  • had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography

结局指标

主要结局

Using Image-Pro Plus 6.0 software to measure myocardial fibrosis

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Major adverse cardiac events after the inclusion of the study(Major adverse cardiac events happened after inclusion of this study,up to 5 years)

研究者

发起方
Xie Mingxing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xie Mingxing

Department of Ultrasound, Union Hospital

Wuhan Union Hospital, China

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