To Study and Explore the Predictive Effect of Insulin Resistance-related Indicators on In-stent Restenosis After Coronary Stent Implantation

May 22, 2026 updated by: Qilu Hospital of Shandong University

The Predictive Effect of Insulin Resistance Metabolic Score on In-stent Restenosis After Coronary Stent Implantation

Based on previous studies on insulin resistance and cardiovascular diseases, we believe that the insulin resistance metabolic score also has certain predictive value for the prognosis of in-stent restenosis after coronary stent implantation. The main purpose of this study is to explore the predictive effect of the insulin resistance metabolic score on in-stent restenosis after coronary stent implantation and to discuss a reasonable control level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Observational studies do not design intervention measures

Detailed Description

Coronary atherosclerotic heart disease, especially acute myocardial infarction, remains the leading cause of death worldwide. Despite the development and improvement of percutaneous coronary intervention (PCI) and drug therapy, which have significantly improved survival rates and clinical outcomes, the unresolved problem of in-stent restenosis (ISR) remains a key factor limiting the therapeutic effect. Therefore, identifying and studying the risk factors and formation mechanisms of in-stent restenosis is an important clinical step in preventing and treating in-stent restenosis. Moreover, an increasing number of studies have shown that IR may have a significant impact on the occurrence and progression of in-stent restenosis (ISR). The traditional quantitative techniques for assessing IR are limited by cost, time, and manpower, while new biomarkers overcome these limitations and become a clinically feasible alternative with cardiovascular disease prediction capabilities. However, there is currently no large amount of data to prove the relationship between metabolic syndrome-insulin resistance (METS-IR) and in-stent restenosis (ISR). Therefore, we designed a retrospective study on patients with recurrent chest pain after percutaneous coronary intervention to evaluate the potential association between subepithelial restenosis (ISR) and metabolic syndrome-insulin resistance (METS-IR), thereby providing a basis for evaluating METS-IR as a possible risk indicator for ISR in patients after percutaneous coronary intervention.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shandong
  - Jinan, Shandong, China, 250012
    - Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

We retrospectively collected the clinical data of patients with recurrent chest pain after PCI and requiring repeated angiography from January 2022 to November 2025, which were obtained from electronic medical records.

Description

Inclusion Criteria:

Age ≥45 years
Patients with a history of percutaneous coronary intervention (PCI) with stent implantation
Patients who underwent repeat coronary angiography during follow-up
Complete clinical data available, including echocardiography, 24-hour ambulatory electrocardiogram, NT-proBNP, liver and kidney function tests, and blood biochemical tests

Exclusion Criteria:

Previous coronary artery bypass grafting
Lesions treated only with balloon angioplasty without stent implantation
Clinical manifestations of heart failure, structural cardiomyopathy, congenital heart disease, or significant valvular heart disease
Severe hepatic or renal dysfunction, such as estimated glomerular filtration rate <30 mL/min/1.73 m²
Incomplete clinical or angiographic data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of in-stent restenosis greater than 50% and greater than 70% assessed by follow-up coronary angiography Time Frame: During follow-up coronary angiography within 6-60 months after PCI	In-stent restenosis was defined as recurrent luminal diameter stenosis within the stented segment or within 5 mm proximal or distal to the stent edges, as determined by follow-up coronary angiography. Percent diameter stenosis was used to quantify the severity of restenosis. Participants will be classified according to whether they had in-stent restenosis greater than 50% and greater than 70%, and the outcome will be summarized as the number and percentage of participants in each category.	During follow-up coronary angiography within 6-60 months after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)