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

14 juli 2026 uppdaterad av: Mohammed Ahmed Abd-Elhmied Mohammed, Assiut University
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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

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Deltagandekriterier

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Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

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

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.

Studieplan

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Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Procedur: PCI
All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
No reflow phenomenon
Tidsram: through study completion, an average of 2 year
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
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
Tidsram: 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.
through study completion, an average of 2 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
MACEs
Tidsram: through study completion, an average of 2 year
3. To assess the relationship between insulin resistance markers and in-hospital major adverse cardiac events (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
Tidsram: 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.
through study completion, an average of 2 year

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Sponsor

Assiut University

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 augusti 2028

Avslutad studie (Beräknad)

1 augusti 2029

Studieregistreringsdatum

Först inskickad

11 juli 2026

Först inskickad som uppfyllde QC-kriterierna

11 juli 2026

Första postat (Faktisk)

15 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • noreflow in STEMI

Plan för individuella deltagardata (IPD)

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