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Recruiting NCT07026708

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

Observational ACS (Acute Coronary Syndrome) Myocardial Infarction (MI) Myocardial Inflammation Inflammation Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation, Inflammation Biomarkers. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Albania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Neutrophil-to-Lymphocyte Ratio (NLR) [Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months]
  • Mortality (all cause mortality and cardiovascular mortality) [Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months]
  • MACE (Major Acute Coronary Events) [Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months]
Secondary outcome measures (4)
  • Difference in Mean NLR Between STEMI and NSTEMI Patients [Time frame: At hospital admission]
  • Association Between High NLR and Presence of Multivessel Coronary Artery Disease [Time frame: During initial coronary angiography]
  • Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol) [Time frame: Within 48 hours of hospital admission]
  • Correlation Between NLR and Peak Troponin Levels [Time frame: During hospitalization (within first 5 days of admission)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Albania · 1 center
  • Faculty of Medicine Tirana — Tirana

Identifiers

NCT: NCT07026708 · 3232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗