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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Neutrophil-to-Lymphocyte Ratio (NLR) [Срок оценки: 6 months post-ACS with a potential prolonged period of roughly 12 months]
• Mortality (all cause mortality and cardiovascular mortality) [Срок оценки: 6 months post-ACS with a potential prolonged period of roughly 12 months]
• MACE (Major Acute Coronary Events) [Срок оценки: 6 months post-ACS with a potential prolonged period of roughly 12 months]

Вторичные конечные точки (4)

• Difference in Mean NLR Between STEMI and NSTEMI Patients [Срок оценки: At hospital admission]
• Association Between High NLR and Presence of Multivessel Coronary Artery Disease [Срок оценки: During initial coronary angiography]
• Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol) [Срок оценки: Within 48 hours of hospital admission]
• Correlation Between NLR and Peak Troponin Levels [Срок оценки: During hospitalization (within first 5 days of admission)]

Критерии участия

Критерии включения

\- 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Albania · 1 центр

• Faculty of Medicine Tirana — Tirana

Идентификаторы

NCT: NCT07026708 · 3232

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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