In-stent Restenosis and Pericoronary Fat Attenuation Index | NCT05512832

Studies
In-stent Restenosis and Pericoronary Fat Attenuation Index

NCT05512832

Sponsor

RenJi Hospital

Status

Completed

Last Update Posted

Aug 23, 2022Actual

Enrollment

126Actual

Phase

Not provided

Conditions

In-stent Restenosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Aug 15, 2022Actual

First Submitted Date

Aug 17, 2022

First Submission Date that Met QC Criteria

Aug 21, 2022

First Posted Date

Aug 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2022

Last Update Posted Date

Aug 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Song Ding	RenJi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine		Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided