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In-stent Restenosis and Pericoronary Fat Attenuation Index

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05512832
Collaborator
(none)
126
Enrollment
1
Location
31.4
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    126 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2022
    Actual Study Completion Date :
    Aug 15, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Fat attenuation index (FAI) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Principal Investigator: Song Ding, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05512832
    Other Study ID Numbers:
    • EARLY-ISR FAI
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    pericoronary fat attenuation index

    Study Results

    No Results Posted as of Aug 23, 2022