In-stent Restenosis and Pericoronary Fat Attenuation Index

August 21, 2022 updated by: RenJi Hospital

Construction and Evaluation of Clinical Prediction Model of In-stent Restenosis After Percutaneous Coronary Intervention by Pericoronary Fat Attenuation Index and Radiomics Characteristics

This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.

Study Overview

Status

Completed

Conditions

In-stent Restenosis

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200127
    - Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary heart disease who have undergone PCI and followed up angiography 9 to 24 months after PCI

Description

Inclusion Criteria:

Patients with coronary heart disease who have undergone PCI;
Patients followed up coronary angiography 9 to 24 months after PCI;
Patients received chest CT examination during inpatient/outpatient follow-up;

Exclusion Criteria:

Patients with diseases of the immune system;
Patients with history of tumor diseases;
Patients with chronic/acute infectious diseases;
Image quality is not sufficient for analysis;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
ISR Patient developed in-stent restenosis 9-24 months after stenting
no ISR Patients were free of in-stent restenosis 9-24 months after stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat attenuation index (FAI) Time Frame: 2022.8.15-2023.8.14	The pericoronary FAI was defined as the mean CT attenuation of the pericoronary adipose tissue (-190 to -30 HU). Peri-stent FAI was measured around the stent segment of all 3 major epicardial coronary vessels.	2022.8.15-2023.8.14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

August 15, 2022

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (ACTUAL)

August 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)