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

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: Coronary Artery Disease; In-stent Restenosis
• 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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

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	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

• Sponsor: Qilu Hospital of Shandong University

Study record dates

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): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: KYLL-2025-11-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No