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STEMINCT07155395

Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI

An observational study of STEMI and Diabete Mellitus, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
STEMI, Diabete Mellitus
How many people
1,000 participants
Where
No sites listed yet
Study dates
Oct 2025to Apr 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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).
Show all 15Show fewer
  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Relationship Between Inflammatory and Hematological Indices and Coronary Artery Disease Severity and Outcome Among Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention

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?

Read more

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.

Read the detailed description

ST-segment Elevation Myocardial Infarction (STEMI) is a critical form of Acute Coronary Syndrome (ACS), resulting from abrupt plaque rupture and thrombotic coronary occlusion. Despite the widespread application of Primary Percutaneous Coronary Intervention (PPCI), STEMI remains one of the leading causes of mortality. Therefore, early stratification and prediction of outcomes is essential.

Recent evidence highlights that, in addition to thrombosis, inflammation plays a crucial role in the pathophysiology of ACS. This has prompted increasing interest in novel inflammatory and hematological biomarkers as promising prognostic tools. These indices are simple, cost-effective, and clinically relevant for outcome prediction.

The markers evaluated in this study include both inflammatory indices (e.g., C-reactive protein [CRP], Neutrophil-to-Albumin Ratio [NAR]) and thrombotic/hematological indices (e.g., Red Cell Distribution Width [RDW], Platelet Distribution Width [PDW], Hemoglobin-to-Red Cell Distribution Width ratio [Hb/RDW], and RDW/PDW ratio). Some of these have already been established as strong predictors of adverse outcomes in STEMI patients, while others remain under investigation. Moreover, their differential prognostic value in diabetic versus non-diabetic STEMI populations remains an area of ongoing research.

Among the markers for inflammation, C-reactive protein (CRP) has been shown to be strongly associated with increased in-hospital mortality among STEMI patients. Another important marker is the Neutrophil-to-Albumin Ratio (NAR), which combines indicators of systemic inflammation and nutritional status. Higher NAR levels have been linked with poor in-hospital outcomes in STEMI.

This study also evaluates hematological and thrombotic indices. Red Cell Distribution Width (RDW), an indicator of anisocytosis, is a well-studied parameter. Increased RDW levels have been associated with worse outcomes in cardiovascular diseases (CVD) and heart failure. Platelet Distribution Width (PDW)-a marker of platelet activation and heterogeneity-has been identified as a strong independent predictor of the no-reflow phenomenon. An elevated RDW/PDW ratio is thought to represent systemic stress and a prothrombotic state, making it a compelling predictor of poor clinical and angiographic outcomes such as no-reflow.

The Hemoglobin-to-Red Cell Distribution Width ratio (Hb/RDW) is a novel indicator. A lower Hb/RDW ratio reflects reduced tissue oxygenation and erythropoietic dysfunction, both of which are linked to poor myocardial recovery, no-reflow, and higher SYNTAX scores.

The no-reflow phenomenon, which these markers help anticipate, is defined as inadequate myocardial perfusion through a segment of the coronary circulation in the absence of mechanical obstruction.

In addition to traditional markers, the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammatory Response Index (SIRI) have recently gained attention. Both are calculated using peripheral blood counts and provide insight into the interplay between inflammation, thrombosis, and immune regulation:

Systemic Immune-Inflammation Index (SII): Platelet count × Neutrophil count / Lymphocyte count.

This index combines neutrophil-driven inflammation, platelet-related thrombosis, and lymphocyte-mediated immune regulation. SII has been recognized as a powerful predictor of no-reflow, MACE, and mortality in cardiovascular patients.

Systemic Inflammatory Response Index (SIRI): Monocyte count × Neutrophil count / Lymphocyte count.

This index reflects systemic inflammation and monocyte activity in atherosclerosis. Elevated SIRI has been associated with higher SYNTAX scores, no-reflow, and adverse cardiovascular outcomes.

Thus, exploring the association between different hematologic-inflammatory indices-including Hb/RDW, RDW/PDW, NAR, SII, SIRI, Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR)-with no-reflow, coronary artery disease severity, and short-term outcomes in diabetic versus non-diabetic STEMI patients undergoing PPCI remains clinically relevant and needed.

Keywords
STEMI, Diabetes, No reflow, SYNTAX, Hb/RDW, RDW/PDW, NAR, SIRI, SII, CRP, PPCI
Medical subject headings
ST Elevation Myocardial Infarction, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07155395
Study groupRoleWhat they receive
Diabetic STEMI PatientsPatients presenting with ST-segment elevation myocardial infarction (STEMI) and a confirmed diagnosis of diabetes mellitus, undergoing primary percutaneous coronary intervention (PCI).
Non-Diabetic STEMI PatientsPatients presenting with STEMI and no history or diagnosis of diabetes, undergoing primary PCI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Peri-procedural

  2. 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.

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

Secondary outcomes (1)
  1. 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 over the 6-month follow-up period.

    Measured: Up to 6 months post-PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07155395
Sponsor's protocol ID
Markers in Diabetic STEMI
Status last verified
Sep 2025
First submitted
24 Aug 2025
Last updated
4 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36737704
  • Milano et al., 2019 (CRP predictor in STEMI; Int J Cardiovasc Sci)

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

  • 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.

    PubMed 31628741
  • 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.

    PubMed 27348163
  • 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.

    PubMed 28055283
  • 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.

    PubMed 32912972
  • 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.

    PubMed 34065132

Questions about this trial

What is this clinical trial studying?

An observational study of STEMI and Diabete Mellitus, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Emil Efraim (+201091620534, David.17289572@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: Peri-procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07155395, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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