NCT07706335

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Aug 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 11, 2026

Last Update Submit

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.

Procedure: PCI

Interventions

PCIPROCEDURE

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

Type 2 diabetic patient

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

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.

    PMID: 20488311BACKGROUND
  • Pathak R, Hauer-Jensen M. Particle Beam may have Higher Effectiveness in Treating Chemo-resistant Cancers than Low-LET Photon Beam Therapy. Res Rev J Pharm Pharm Sci. 2015 Apr-Jun;4(2):1-2. Epub 2015 Jun 14. No abstract available.

    PMID: 26779544BACKGROUND
  • Xie X, Tang B, Zhou J, Gao Q, Zhang P. Inhibition of the PI3K/Akt pathway increases the chemosensitivity of gastric cancer to vincristine. Oncol Rep. 2013 Aug;30(2):773-82. doi: 10.3892/or.2013.2520. Epub 2013 Jun 5.

    PMID: 23743572BACKGROUND
  • Matza D, Badou A, Jha MK, Willinger T, Antov A, Sanjabi S, Kobayashi KS, Marchesi VT, Flavell RA. Requirement for AHNAK1-mediated calcium signaling during T lymphocyte cytolysis. Proc Natl Acad Sci U S A. 2009 Jun 16;106(24):9785-90. doi: 10.1073/pnas.0902844106. Epub 2009 Jun 2.

    PMID: 19497879BACKGROUND
  • Kacerova S, Muchova M, Doudova H, Munster L, Hanulikova B, Valaskova K, Kasparkova V, Kuritka I, Humpolicek P, Vichova Z, Vasicek O, Vicha J. Chitosan/dialdehyde cellulose hydrogels with covalently anchored polypyrrole: Novel conductive, antibacterial, antioxidant, immunomodulatory, and anti-inflammatory materials. Carbohydr Polym. 2024 Mar 1;327:121640. doi: 10.1016/j.carbpol.2023.121640. Epub 2023 Nov 28.

    PMID: 38171669BACKGROUND
  • Liu J, Teh WL, Tan RHS, Chang SSH, Lau BJ, Chandwani N, Tor PC, Subramaniam M. Evaluating a maladaptive personality-informed model of social support and post-traumatic stress disorder. J Affect Disord. 2024 Sep 15;361:209-216. doi: 10.1016/j.jad.2024.05.164. Epub 2024 May 29.

    PMID: 38821368BACKGROUND
  • Calafate S, Ozturan G, Thrupp N, Vanderlinden J, Santa-Marinha L, Morais-Ribeiro R, Ruggiero A, Bozic I, Rusterholz T, Lorente-Echeverria B, Dias M, Chen WT, Fiers M, Lu A, Vlaeminck I, Creemers E, Craessaerts K, Vandenbempt J, van Boekholdt L, Poovathingal S, Davie K, Thal DR, Wierda K, Oliveira TG, Slutsky I, Adamantidis A, De Strooper B, de Wit J. Early alterations in the MCH system link aberrant neuronal activity and sleep disturbances in a mouse model of Alzheimer's disease. Nat Neurosci. 2023 Jun;26(6):1021-1031. doi: 10.1038/s41593-023-01325-4. Epub 2023 May 15.

    PMID: 37188873BACKGROUND

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNo-Reflow Phenomenon

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Mohammed Ahmed Abdelhmied

CONTACT

Ahmed Mohammed Ali obiedallah

CONTACT

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