NCT05512832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

August 17, 2022

Last Update Submit

August 21, 2022

Conditions

In-stent Restenosis

Keywords

pericoronary fat attenuation index

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Study Officials

  • Song Ding

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 23, 2022

Study Start

January 1, 2020

Primary Completion

June 30, 2022

Study Completion

August 15, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)