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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07026708
Acronym
TIRANA (ACS)
Enrollment
1600
Registered
2025-06-18
Start date
2024-11-01
Completion date
2027-06-01
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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. 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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
University Hospital Centre Mother Teresa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MACE (Major Acute Coronary Events)6 months post-ACS with a potential prolonged period of roughly 12 monthsMACE 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 .
Neutrophil-to-Lymphocyte Ratio (NLR)6 months post-ACS with a potential prolonged period of roughly 12 monthsAssociation 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.
Mortality (all cause mortality and cardiovascular mortality)6 months post-ACS with a potential prolonged period of roughly 12 monthsMortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .

Secondary

MeasureTime frameDescription
Difference in Mean NLR Between STEMI and NSTEMI PatientsAt hospital admissionThis 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
Correlation Between NLR and Peak Troponin LevelsDuring 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.
Association Between High NLR and Presence of Multivessel Coronary Artery DiseaseDuring initial coronary angiographyThis outcome explores whether elevated NLR values are associated with the presence of multivessel disease identified during coronary angiography.
Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)Within 48 hours of hospital admissionThis 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.

Countries

Albania

Contacts

Primary ContactMartiola Kola, MD
martiola.kola@gmail.com003553410998
Backup ContactAndi Rroku, MD
andi.rroku@dhzc-charite.de+4930450613689

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026