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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07614763
Enrollment
1000
Registered
2026-05-29
Start date
2022-01-01
Completion date
2025-11-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, In-stent Restenosis

Brief summary

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.

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.

Interventions

OTHERObservational studies do not design intervention measures

Observational studies do not design intervention measures

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of in-stent restenosis greater than 50% and greater than 70% assessed by follow-up coronary angiographyDuring follow-up coronary angiography within 6-60 months after PCIIn-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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026