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NCT Number: NCT07706335

Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.

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.

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Key information

About this study

Successful restoration of epicardial coronary artery patency in acute myocardial infarction (AMI) does not always guarantee adequate myocardial tissue perfusion or effective salvage of ischemic myocardium. In a substantial proportion of patients, microvascular dysfunction persists despite successful recanalization after percutaneous coronary intervention (PCI), limiting the expected clinical benefit of reperfusion therapy. This condition, known as the no-reflow phenomenon, is characterized by inadequate myocardial perfusion in the absence of angiographic evidence of mechanical vessel obstruction. No-reflow occurs in 2-60% of patients with ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse ventricular remodeling, malignant arrhythmias, heart failure, and increased short- and long-term mortality.

Distal embolization of thrombus and plaque debris during PCI is a major mechanism underlying microvascular obstruction and no-reflow, emphasizing the importance of identifying high-risk coronary lesions before intervention. The SYNTAX score, an angiographic tool reflecting coronary lesion complexity, has been shown to predict clinical outcomes and the occurrence of no-reflow in patients undergoing PCI. Patients with type 2 diabetes mellitus (T2DM) represent a particularly vulnerable group, as they frequently exhibit more complex coronary lesions and a higher incidence of no-reflow.

Insulin resistance (IR) plays a central role in endothelial dysfunction, vascular inflammation, and atherothrombosis. The triglyceride-glucose (TyG) index, a simple and reliable surrogate of IR, has been associated with adverse cardiovascular outcomes and has recently been shown to predict the occurrence of no-reflow in STEMI patients with T2DM undergoing PCI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Type 2 Diabetes Mellitus patients .
  • Undergoing PCI for STEMI.
  • Written informed consent obtained.

Exclusion criteria

  • 1. 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).

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.

Treatment and study plan

PCI

Procedure

All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)

Primary outcomes

  1. SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)

    Time frame: through study completion, an average of 2 year

    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.

  2. No reflow phenomenon

    Time frame: through study completion, an average of 2 year

    • To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.

Secondary outcomes

  1. MACEs

    Time frame: through study completion, an average of 2 year

    • To assess the relationship between insulin resistance markers and in-hospital major adverse cardiac events (MACEs).
  2. Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon

    Time frame: through study completion, an average of 2 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohammed Ali obiedallah

CONTACT

[email protected]

0100755 6396 ext. Professor

Mohammed Ahmed Abdelhmied

CONTACT

[email protected]

01147349160

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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