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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

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Deltagelseskriterier

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Berettigelseskriterier

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  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
Procedure: PCI
All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
No reflow phenomenon
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MACEs
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Assiut University

Publikationer og nyttige links

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Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • noreflow in STEMI

Plan for individuelle deltagerdata (IPD)

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