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

Xie Mingxing

Status: Not yet enrolling

Conditions: Heart Transplant

Study type: Observational

Funder types: Other

Identifiers

NCT04966988

2021 V 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 4 patient groups

CAV 0(Not significant)

Description:

No detectable angiographic lesion

CAV 1 (Mild)

Description:

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)

Description:

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

CAV 3 (Severe)

Description:

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