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

NCT ID: NCT04966988

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAV 0(Not significant)

No detectable angiographic lesion

No interventions assigned to this group

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

No interventions assigned to this group

CAV 2 (Moderate)

Angiographic LM \<50%; a single primary vessel≥70%, or isolated branch stenosis ≥70% in branches

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xie Mingxing

OTHER

Sponsor Role lead

Responsible Party

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Xie Mingxing

MD, PhD,FACC, FAHA, FASE

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ultrasound, Union Hospital, Wuhan, China

Central Contacts

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Li Zhang, PhD

Role: CONTACT

18907131488

Shuangshuang Zhu, MD

Role: CONTACT

15971428009

Other Identifiers

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2021 V 1.0

Identifier Type: -

Identifier Source: org_study_id

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