Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI

NCT07155395 | Not Yet Recruiting

• 1 other identifier: Markers in Diabetic STEMI
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

ST-segment Elevation Myocardial Infarction (STEMI) remains a major cause of mortality despite the adoption of Primary Percutaneous Coronary Intervention (PPCI) as the standard treatment. However, outcomes still vary significantly among patients, especially between diabetic and non-diabetic cohorts. The research question driving this study is: Can hematologic, inflammatory, and thrombotic indices serve as reliable prognostic tools in predicting the no-reflow phenomenon and coronary artery disease (CAD) severity in STEMI patients, particularly among those with diabetes mellitus? Recent literature identifies inflammation as a key contributor to the pathogenesis and outcomes of Acute Coronary Syndrome (ACS), including the no-reflow phenomenon and Major Adverse Cardiovascular Events (MACE). Markers such as C-reactive protein (CRP), Neutrophil-to-Albumin Ratio (NAR), Red Cell Distribution Width (RDW), Platelet Distribution Width (PDW), Hemoglobin-to-Red Cell Distribution Width ratio (Hb/RDW), and the RDW/PDW ratio have shown individual correlations with poor outcomes. Emerging indices such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammatory Response Index (SIRI) further integrate immune and inflammatory components and have shown promise in early risk stratification. The current strategy in many cardiac centers relies on angiographic and clinical indicators, which may be insufficient for individualized risk prediction. Hence, incorporating accessible and cost-effective blood-based markers could significantly enhance prognostic accuracy. The rationale of this research lies in comparing these indices in diabetic versus non-diabetic STEMI patients, aiming to stratify risk, predict no-reflow, assess coronary artery disease burden using the SYNTAX score, and identify those at risk for early adverse outcomes.

Conditions

STEMI; Diabete Mellitus

Keywords

STEMI; Diabetes; No reflow; SYNTAX; Hb/RDW; RDW/PDW; NAR; SIRI; SII; CRP; PPCI

Outcome Measures

Primary Outcomes (2)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Composite outcome including heart failure, fatal arrhythmia, death, re-infarction, stroke, and urgent target vessel revascularization. The prognostic value of various biomarkers (Hb/RDW, RDW/PDW, NAR, SII, SIRI) will be assessed in diabetic vs. non-diabetic STEMI patients during admission.

  Peri-procedural

• Angiographic outcomes including No Reflow Phenomenon

  Assessment of angiographic outcomes following primary percutaneous coronary intervention (PPCI), with a specific focus on the incidence of the no-reflow phenomenon. No-reflow will be defined as inadequate myocardial perfusion in the absence of mechanical obstruction.

  At time of Primary PCI (within 24 hours of admission)

Secondary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Up to 6 months post-PCI

Study Arms (2)

Diabetic STEMI Patients

Patients presenting with ST-segment elevation myocardial infarction (STEMI) and a confirmed diagnosis of diabetes mellitus, undergoing primary percutaneous coronary intervention (PCI).

Non-Diabetic STEMI Patients

Patients presenting with STEMI and no history or diagnosis of diabetes, undergoing primary PCI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients present with STEMI and undergoing primary percutaneous coronary intervention in Assiut university heart hospital (AUHH). Patients will be categorized into 2 groups: Diabetics and non-diabetics based on HbA1c.

You may qualify if:

• Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
• Managed with primary percutaneous coronary intervention (PPCI).

You may not qualify if:

• Patients not eligible for PPCI.
• Patients who underwent thrombolytic therapy or received anti-thrombotics prior to hospital arrival.
• Prior coronary intervention: history of PCI or CABG.
• Known hematological disorders:
• Thalassemia (microcytic anemia, normal iron profile, HbA2 ≥ 3.5% or elevated HbF).
• Myelodysplastic syndromes (unexplained cytopenias with ≥10% dysplasia in bone marrow aspirate).
• Leukemia (persistent leukocytosis or pancytopenia, blasts ≥20% in peripheral blood).
• Active infection or sepsis at admission (e.g., fever, leukocytosis, elevated CRP \<100 mg/L without cardiac cause).
• Known autoimmune or chronic inflammatory diseases (e.g., systemic lupus erythematosus).
• Known or newly diagnosed malignancy.
• End-stage renal disease (eGFR \<30 ml/min/1.73 m² or on dialysis).
• Advanced hepatic impairment (Child-Pugh class C; bilirubin \>3 mg/dL or ALT/AST \>3× upper limit of normal).
• Recent blood transfusion within 3 months.
• Recent use of steroids, chemotherapy, or immunosuppressive drugs.
• Mechanical complications or cardiogenic shock prior to or during STEMI presentation (e.g., papillary muscle rupture, ventricular septal defect, need for intra-aortic balloon pump).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Li H, Xu Y. Association between red blood cell distribution width-to-albumin ratio and prognosis of patients with acute myocardial infarction. BMC Cardiovasc Disord. 2023 Feb 3;23(1):66. doi: 10.1186/s12872-023-03094-1.

  PMID: 36737704 BACKGROUND

• Milano et al., 2019 (CRP predictor in STEMI; Int J Cardiovasc Sci)

  BACKGROUND

• Kılıç et al., 2024 (Hb/RDW ratio in ACS)

  BACKGROUND

• Cui H, Ding X, Li W, Chen H, Li H. The Neutrophil Percentage to Albumin Ratio as a New Predictor of In-Hospital Mortality in Patients with ST-Segment Elevation Myocardial Infarction. Med Sci Monit. 2019 Oct 19;25:7845-7852. doi: 10.12659/MSM.917987.

  PMID: 31628741 BACKGROUND

• Sahinkus S, Cakar M, Yaylaci S, Aydin E, Can Y, Kocayigit I, Osken A, Akdemir R, Gunduz H. HEMATOLOGICAL MARKERS OF THE NO-REFLOW PHENOMEN ON IN-PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION. Georgian Med News. 2016 May;(254):26-32.

  PMID: 27348163 BACKGROUND

• Milwidsky A, Ziv-Baran T, Letourneau-Shesaf S, Keren G, Taieb P, Berliner S, Shacham Y. CRP velocity and short-term mortality in ST segment elevation myocardial infarction. Biomarkers. 2017 May-Jun;22(3-4):383-386. doi: 10.1080/1354750X.2017.1279218. Epub 2017 Jan 25.

  PMID: 28055283 BACKGROUND

• Bao D, Luo G, Kan F, Wang X, Luo J, Jiang C. Prognostic value of red cell distribution width in patients undergoing percutaneous coronary intervention: a meta-analysis. BMJ Open. 2020 Sep 10;10(9):e033378. doi: 10.1136/bmjopen-2019-033378.

  PMID: 32912972 BACKGROUND

• Babes EE, Zaha DC, Tit DM, Nechifor AC, Bungau S, Andronie-Cioara FL, Behl T, Stoicescu M, Munteanu MA, Rus M, Toma MM, Brisc C. Value of Hematological and Coagulation Parameters as Prognostic Factors in Acute Coronary Syndromes. Diagnostics (Basel). 2021 May 9;11(5):850. doi: 10.3390/diagnostics11050850.

  PMID: 34065132 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohamed Abdelghany

  Assiut University

  STUDY DIRECTOR

• Heba Mahmoud Elnaggar

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

David Emil Efraim

CONTACT

+201091620534; David.17289572@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Cardiologist

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09