跳至主要内容
临床试验/NCT07026708
NCT07026708招募中不适用

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

University Hospital Centre Mother Teresa1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,600
试验地点
1
主要终点
Neutrophil-to-Lymphocyte Ratio (NLR)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 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

排除标准

  • 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.

结局指标

主要结局

Neutrophil-to-Lymphocyte Ratio (NLR)

时间窗: 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.

Mortality (all cause mortality and cardiovascular mortality)

时间窗: 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 .

MACE (Major Acute Coronary Events)

时间窗: 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 .

次要结局

  • 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))

研究者

发起方
University Hospital Centre Mother Teresa
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验