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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Heart Transplant

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