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
• Status: Completed
• 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
• 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;

Related Conditions & MeSH terms

• In-stent Restenosis

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