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NCT Number: NCT07026708

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

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. Differences in mean NLR between STEMI and NSTEMI patients. 2. Association between elevated NLR and the presence of multivessel coronary artery disease on angiography. 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)

This study aims to contribute to the identification of easily accessible and cost-efficient biomarkers that can aid clinicians in early risk stratification of ACS survivors. A strong correlation between high NLR values and increased post-discharge mortality would suggest that inflammation plays a key role in patient prognosis and could potentially influence post-ACS management strategies.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Tirana

Tirana, 1005, Albania

Location status: Recruiting

Location contact

Alban Dibra, Prof . Dr, PhD

CONTACT

[email protected]

+355682085837

Alban Dibra, Prof. Dr, Phd

PRINCIPAL_INVESTIGATOR

Andi Rroku, MD

PRINCIPAL_INVESTIGATOR

Martiola Kola

CONTACT

[email protected]

+355693410998

Martiola Kola

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Neutrophil-to-Lymphocyte Ratio (NLR)

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

    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.

  2. Mortality (all cause mortality and cardiovascular mortality)

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

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

  3. MACE (Major Acute Coronary Events)

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

    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 .

Secondary outcomes

  1. Difference in Mean NLR Between STEMI and NSTEMI Patients

    Time frame: At hospital admission

    This outcome evaluates the variation in mean NLR values among patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) versus Non-ST-Elevation Myocardial Infarction (NSTEMI).

    Time Frame: At hospital admission

  2. Association Between High NLR and Presence of Multivessel Coronary Artery Disease

    Time frame: During initial coronary angiography

    This outcome explores whether elevated NLR values are associated with the presence of multivessel disease identified during coronary angiography.

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

    Time frame: Within 48 hours of hospital admission

    This outcome assesses the relationship between the NLR and other laboratory markers of inflammation and cardiovascular risk, including platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and HDL-cholesterol levels.

  4. Correlation Between NLR and Peak Troponin Levels

    Time frame: During hospitalization (within first 5 days of admission)

    This outcome evaluates the correlation between baseline NLR and peak troponin levels as a surrogate marker for myocardial infarction size.

Study contacts

Contact information is provided by the study sponsor or research team.

Andi Rroku, MD

CONTACT

[email protected]

+4930450613689 ext. +4917635896065

Martiola Kola, MD

CONTACT

[email protected]

003553410998

Sponsors and collaborators

Lead sponsor

University Hospital Centre Mother Teresa

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

Target Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome - TIRANA (ACS) Prospective REGISTRY

Acronym: TIRANA (ACS)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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