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NCT04966988 Clinical Trial

Multimodal Imaging Evaluation and Prognostic Analysis of Cardiac Allograft Vasculopathy in Heart Transplantation

Heart Transplant Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04966988
Other study ID # 2021 V 1.0
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date August 1, 2026

Study information
Verified date July 2021
Source Wuhan Union Hospital, China
Contact Li Zhang, PhD
Phone 18907131488
Email zli429@hust.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

Description:

This study will enrolled 1000 HT patients, and the cardiac allograft vasculopathy will be evaluated by multimodal imaging technology. The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date August 1, 2026
Est. primary completion date August 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: • Heart transplantation after January 1st, 2015. Exclusion Criteria: •Age < 18 years at the time of transplantation; Died within 48 h; Heart-lung transplantation; Heart/kidney transplantation; Re-transplanted within 7 days after transplantation.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Xie Mingxing Guangdong Provincial People's Hospital, Henan Provincial People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Wuhan Asia Heart Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary All cause death All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records up to 10 year
Secondary Major adverse cardiac events Major adverse cardiac events after the inclusion of the study was obtained via telephone interview with family members; contact with his/her physicians; or hospital records 5 year and 10 year
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