Clincosm LogoSign in Get a demo

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

Sponsor
Xie Mingxing (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04966988
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Shanghai Zhongshan Hospital (Other), Henan Provincial People's Hospital (Other), Wuhan Asia Heart Hospital (Other), Guangdong Provincial People's Hospital (Other)
1,000
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Anticipated Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    CAV 0(Not significant)

    No detectable angiographic lesion
    CAV 1 (Mild)

    Angiographic left main (LM) <50%, or primary vessel with maximum lesion of <70%, or any branch stenosis <70% (including diffuse narrowing) without allograft dysfunction
    CAV 2 (Moderate)

    Angiographic LM <50%; a single primary vessel≥70%, or isolated branch stenosis ≥70% in branches
    CAV 3 (Severe)

    Angiographic LM≥50%, or two or more primary vessels ≥70% stenosis, or isolated branch stenosis≥70%in all 3 systems; or CAV1 or CAV2 with allograft dysfunction (defined as LVEF≤45% usually in the presence of regional wall motion abnormalities) or evidence of significant restrictive physiology

    Outcome Measures

    Primary Outcome Measures

    1. All cause death [up to 10 year]

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

    Secondary Outcome Measures

    1. Major adverse cardiac events [5 year and 10 year]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Li Zhang, PhD, Department of Ultrasound, Union Hospital, Wuhan, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xie Mingxing, MD, PhD,FACC, FAHA, FASE, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04966988
    Other Study ID Numbers:
    • 2021 V 1.0
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 19, 2021