A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation

NCT04974372 | Unknown

• 1 other identifier: 2021V1.0
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (4)

• Using Image-Pro Plus 6.0 software to measure myocardial fibrosis

  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

  the measurement of myocardial fibrosis up to 1 year after heart transplant

• All cause death after the inclusion of the study

  All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records every year

  All cause death happened after inclusion of this study, up to 5 years

• Acute rejection after the inclusion of the study

  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

  Acute rejection happened after inclusion of this study, up to 5 years

• Cardiac allograft vasculopathy after the inclusion of the study

  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

  Cardiac allograft vasculopathy happened after inclusion of this study, up to 5 years

Secondary Outcomes (1)

• Major adverse cardiac events after the inclusion of the study

  Major adverse cardiac events happened after inclusion of this study，up to 5 years

Study Arms (2)

HT group

Patients have echocardiography examination before and after heart transplantation.

Control group

healthy volunteers who had no history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography were enrolled as control group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ALL adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography (TTE) for surveillance at their routine follow-up visits at our institution

You may qualify if:

• healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Xie Mingxing: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Officials

• Li Zhang, PhD

  Department of Ultrasound, Union Hospital, Wuhan, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, PhD

CONTACT

18907131488; zli429@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Ultrasound, Union Hospital

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 23, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share