Short Term Outcomes After Primary PCI in Diabetic Patients Treated With Insulin Versus Oral Anti-diabetic Drugs

Not yet recruiting

• Conditions: Diabetes Mellitus; PCI

• Registration Number: NCT06992466
• Lead Sponsor: Assiut University

Brief Summary

• This study aims to compare the short-term clinical and echocardiographic outcomes of primary PCI in diabetic patients treated with insulin versus OADs.

Detailed Description

1. Diabetes mellitus (DM) is a major risk factor for cardiovascular disease (CVD), significantly increasing the risk of myocardial infarction (MI), heart failure, and mortality. Among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with higher rates of multi vessel disease, impaired coronary microcirculation, and poorer outcomes following percutaneous coronary intervention (PCI) compared to non-diabetic patients (1.2.3.4)

2. Diabetes is an independent risk factor for the development of CAD. Coronary arteries in diabetic patients present extensive and diffuse atherosclerosis, longer and more complex lesions than in non-diabetic patients \[5\]. The relative risk of myocardial infarction (MI) is 50% higher in diabetic men and 150% higher in diabetic women \[6\]. Patients with type 2 DM have similar risk for cardiac events as subjects with a prior MI \[7\]. The risk of recurrence of MI in diabetic patients is more than 40% \[8\]. Due to high prevalence of acute MI in diabetic patients, adults with diabetes will lose 30 quality-adjusted life years compared to those without DM \[9\].

3. Primary PCI is the gold-standard treatment for STEMI, offering superior outcomes compared to fibrinolysis. However, diabetic patients exhibit higher rates of in-stent restenosis, stent thrombosis, and recurrent ischemic events, making optimal glycemic control and choice of anti-diabetic therapy critical in improving post-PCI outcomes (10)

4. Cardiac remodeling refers to a spectrum of structural and functional changes that occur in the heart in response to myocardial injury or increased hemodynamic load, such as after myocardial infarction, chronic hypertension, or valvular heart disease. These changes may include alterations in ventricular size, shape, wall thickness, and overall function, and they are strongly associated with adverse cardiovascular outcomes including heart failure and sudden cardiac death.

Echocardiography is a cornerstone non-invasive imaging modality that plays a vital role in the assessment and monitoring of cardiac remodeling. It offers real-time evaluation of cardiac chamber dimensions, wall thickness, ventricular volumes, ejection fraction, myocardial deformation (strain), and diastolic function. These echocardiographic parameters not only reflect the extent of remodeling but also have prognostic significance in various cardiac conditions.(11)

5. Impact of Diabetes Treatment on Cardiovascular Outcomes

The choice of anti-diabetic therapy may influence cardiovascular outcomes in STEMI patients undergoing PCI. There are two main therapeutic strategies for diabetes management:

Insulin therapy: Often used in patients with long-standing or poorly controlled diabetes, but is associated with increased risks of hypoglycemia, weight gain, and potential pro-inflammatory effects, which may contribute to worse cardiovascular outcomes (12.13)

Oral anti-diabetic drugs (OADs): Certain newer agents, such as SGLT2 inhibitors and GLP-1 receptor agonists, have demonstrated cardio protective effects, while others like sulfonylureas may be associated with an increased risk of adverse cardiovascular events (14)

Despite these differences, data on the impact of insulin versus OADs on PCI outcomes remain inconclusive, necessitating further research

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study Start: 2025-05-20
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-01-25
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patients with DM (type 2) undergoing primary PCI for STEMI.1-

Treated with either insulin or OADs prior to admission.2-

3- Age ≥18 year

Exclusion Criteria

• Type 1 DM.1- Patients on both insulin and OADs.2- 3-Prior coronary artery bypass graft (CABG) surgery. 4-Severe renal impairment (eGFR <30 mL/min/1.73m²). 5-Hemodynamically unstable patients 6-moderate to severe VHD 7-Patients who were shifted from OADs to insulin during Follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Term Outcomes after Primary PCI in Diabetic Patients Treated with Insulin Versus Oral Anti-diabetic Drugs	baseline	To compare major adverse cardiovascular events (MACE) in insulin-treated versus OAD-treated diabetic patients undergoing primary PCI.

Secondary Outcome Measures

Name	Time	Method
Echocardiography	baseline	Echocardiographic assessment of cardiac Remodeling early and 3 months post primary PCI

Trial Locations

Locations (1)

Assuit; 🇪🇬 Assuit, Egypt