NCT04966988

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

July 10, 2021

Last Update Submit

July 16, 2021

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Major adverse cardiac events

    5 year and 10 year

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography for surveillance at their routine follow-up

You may qualify if:

  • Heart transplantation after January 1st, 2015.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Li Zhang, PhD

    Department of Ultrasound, Union Hospital, Wuhan, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, PhD

CONTACT

18907131488zli429@hust.edu.cn

Shuangshuang Zhu, MD

CONTACT

1597142800918846032209@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD,FACC, FAHA, FASE

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 19, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share