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NCT05512832 Clinical Trial

In-stent Restenosis and Pericoronary Fat Attenuation Index

In-stent Restenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05512832
Other study ID # EARLY-ISR FAI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date August 15, 2022

Study information
Verified date August 2022
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date August 15, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fat attenuation index (FAI) 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
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