TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome

NCT07026708 | Recruiting DMC

• 1 other identifier: 3232
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Despite advancements in interventional cardiology and medical therapy, mortality remains significant in post-ACS patients, and early risk stratification is essential for optimizing outcomes. Recent studies have suggested that systemic inflammatory markers, such as NLR, are associated with adverse cardiovascular events. It is an easily obtainable and cost-effective laboratory parameter derived from a routine complete blood count. However, its value as an independent predictor of mortality post-ACS has not yet been fully established in our population. The study will include patients aged, admitted with a confirmed diagnosis of ACS (STEMI or Non-STEMI) and treated with percutaneous coronary intervention (PCI). NLR values will be measured from the first blood draw upon hospital admission, 24 and 48 hours post PCI. Patients will be followed up for up to 6 months after discharge through telephone interviews . First, primary outcomes of the study will be the association between NLR values and mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) within 6 months post-ACS. Secondary outcomes will include:

1. 1.Differences in mean NLR between STEMI and NSTEMI patients.
2. 2.Association between elevated NLR and the presence of multivessel coronary artery disease on angiography.
3. 3.Correlation of NLR with other biomarkers, including the platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), high-density lipoprotein (HDL) cholesterol, and maximum troponin levels (as an indicator of myocardial infarction size)

Conditions

ACS (Acute Coronary Syndrome); Myocardial Infarction (MI); Myocardial Inflammation; Inflammation Biomarkers; NSTEMI - Non-ST Segment Elevation MI; STEMI

Keywords

Residual inflammation; Myocardial infarction; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (3)

• Neutrophil-to-Lymphocyte Ratio (NLR)

  Association Between Neutrophil-to-Lymphocyte Ratio (NLR) and Mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) in Post-Acute Coronary Syndrome (ACS) Patients . This outcome assesses the predictive value of NLR levels for mortality within 6 months following an ACS event.

  6 months post-ACS with a potential prolonged period of roughly 12 months

• Mortality (all cause mortality and cardiovascular mortality)

  Mortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .

  6 months post-ACS with a potential prolonged period of roughly 12 months

• MACE (Major Acute Coronary Events)

  MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure in Post-Acute Coronary Syndrome (ACS) Patients .

  6 months post-ACS with a potential prolonged period of roughly 12 months

Secondary Outcomes (4)

• Difference in Mean NLR Between STEMI and NSTEMI Patients

  At hospital admission

• Association Between High NLR and Presence of Multivessel Coronary Artery Disease

  During initial coronary angiography

• Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)

  Within 48 hours of hospital admission

• Correlation Between NLR and Peak Troponin Levels

  During hospitalization (within first 5 days of admission)

Study Arms (1)

Acute Coronary Syndrome Patients

Data Collection: General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.

You may qualify if:

• \- All patients (undergoing PCI, aged 18-85 years) presenting to the cardiology department or/and the cardiology intensive care unit with a diagnosis of ACS

You may not qualify if:

• Patients presenting to the cardiology department or/and the cardiology intensive care unit with diagnoses other than ACS and/or UA. Patients who died before undergoing PCI and those who did not provide a contact number.

Sponsors & Collaborators

• University Hospital Centre Mother Teresa: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Faculty of Medicine Tirana

Tirana, 1005, Albania

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Myocarditis; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies

Study Officials

• Andi Rroku, MD

  Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin

  PRINCIPAL INVESTIGATOR

• Alban Dibra, Prof. Dr, Phd

  University of Medicine, Tirana

  STUDY DIRECTOR

• Martiola Kola, MD

  University of Medicine, Tirana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martiola Kola, MD

CONTACT

003553410998; martiola.kola@gmail.com

Andi Rroku, MD

CONTACT

+4930450613689; andi.rroku@dhzc-charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

AL (1)