Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
1 other identifier
observational
100
0 countries
N/A
Brief Summary
To investigate the relationship between the TyG index, coronary lesion complexity assessed by the SYNTAX score, and the development of the no-reflow phenomenon in STEMI patients with T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
July 16, 2026
July 1, 2026
2 years
July 11, 2026
July 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
Assessment of the association between the triglyceride-glucose (TyG) index and the SYNTAX score in patients with type 2 diabetes mellitus undergoing primary PCI for STEMI. Scale details: Minimum value: 0 Maximum value: No fixed maximum (the score is unbounded and increases according to the number, complexity, and location of coronary lesions). Interpretation: Higher SYNTAX scores indicate greater coronary artery disease complexity and worse angiographic severity.
through study completion, an average of 2 year
No reflow phenomenon
2\. To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
through study completion, an average of 2 year
Secondary Outcomes (2)
MACEs
through study completion, an average of 2 year
Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon
through study completion, an average of 2 year
Study Arms (1)
Type 2 diabetic patient
Inclusion criteria: 1\. Age ≥ 18 years 2.Type 2 Diabetes Mellitus patients . 3.Undergoing PCI for STEMI. 4.Written informed consent obtained. 2.4.5-Exclusion criteria : 1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure. 2. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4. Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous). 5. Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value). 6. Patients with renal impairment (GFR \< 60 mL/min/1.73 m²). 7. Active infection or inflammatory disease. 8. Known autoimmune disease. 9. Malignancy. 10. Type 1 Diabetes Mellitus patients.
Interventions
All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
Eligibility Criteria
Clinical, Laboratory, Insulin Resistance, and Angiographic Assessment Eligible patients with type 2 diabetes mellitus presenting with STEMI and undergoing primary PCI were prospectively evaluated. Clinical data included age, sex, BMI, cardiovascular risk factors, diabetes duration, ischemic time, Killip class, and infarct location. Laboratory investigations included fasting plasma glucose, HbA1c, lipid profile, CBC, serum creatinine, cardiac biomarkers, and hs-CRP. Insulin resistance was assessed using the triglyceride-glucose (TyG) index: ln \[fasting triglycerides × fasting plasma glucose ÷ 2\]. Coronary angiography assessed the infarct-related artery, TIMI flow, thrombus grade, lesion characteristics, and SYNTAX score. The primary endpoint was the occurrence of the no-reflow phenomenon after primary PCI.
You may qualify if:
- Age ≥ 18 years
- Type 2 Diabetes Mellitus patients .
- Undergoing PCI for STEMI.
- Written informed consent obtained.
You may not qualify if:
- \. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
- \. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4.Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
- Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
- Patients with renal impairment (GFR \< 60 mL/min/1.73 m²). 7.Active infection or inflammatory disease. 8.Known autoimmune disease. 9.Malignancy. 10. Type 1 Diabetes Mellitus patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.
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PMID: 37188873BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer of Critical Care Medicine, Department of Internal Medicine, Faculty of Medicine, Assiut University
Study Record Dates
First Submitted
July 11, 2026
First Posted
July 15, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2029
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share