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Not yet recruiting NCT07706335

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

— Observational STEMI No-Reflow Phenomenon Diabetic Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCI.
Who it may be relevant to
Registry conditions: STEMI, No-Reflow Phenomenon, Diabetic Patient. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score) [Time frame: through study completion, an average of 2 year]
  • No reflow phenomenon [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (2)
  • MACEs [Time frame: 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 [Time frame: through study completion, an average of 2 year]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 20488311
  • 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 26779544
  • 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 23743572
  • 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 19497879
  • 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 20 PMID 38171669
  • 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 38821368
  • 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 aberra PMID 37188873

Identifiers

NCT: NCT07706335 · noreflow in STEMI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗