Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Type 2 Diabetes Mellitus patients .
Undergoing PCI for STEMI.
Written informed consent obtained.
Disqualifiers
1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PCI
Procedure/SurgeryAll eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Type 2 diabetic patient1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 2 year2
No reflow phenomenon
2\. To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
MACEs
3\. To assess the relationship between insulin resistance markers and in-hospital major adverse cardiac events (MACEs).
Time frame
through study completion, an average of 2 year2
Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon
The discriminatory performance of the TyG index for predicting the occurrence of the no-reflow phenomenon after primary PCI will be assessed by the area under the ROC curve (AUC), with the optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value reported.
Time frame
through study completion, an average of 2 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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