An observational study in ACS (Acute Coronary Syndrome), Myocardial Infarction (MI) and Myocardial Inflammation, sponsored by University Hospital Centre Mother Teresa. Recruiting at 1 site in Albania. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University Hospital Centre Mother Teresa · Observational
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:
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →This is the only study on the registry with University Hospital Centre Mother Teresa as lead sponsor.
Counted across the registry records on this site, refreshed daily.
General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital".
Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories.
The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale.
Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Data Collection: General patient information, diagnosis, comorbidities, CRP levels, neutrophil and lymphocyte counts, thrombocyte count, HDL cholesterol, LDL cholesterol, and complications (electrical and mechanical) will be collected from the medical records in the cardiology department of our main tertiary hospital "Mother Teresa Hospital". Angiographic data and treatment information will be gathered from standard coronary angiography reports used at our cardiac catheterization laboratories. The follow-up form used for telephone interviews with patients is based on standardized instruments, including the WHO Rose Angina Questionnaire, Seattle Angina Questionnaire, EQ-5D-5L, MacNew Heart Disease Health-Related Quality of Life Questionnaire, McGill Pain Questionnaire, and the MRC Dyspnoea Scale. Patient status will be evaluated at 24 hours, 48 hours, and 6 months after the onset of symptoms. The symptom onset time will be obtained from medical records documented upon patient referral.
Neutrophil-to-Lymphocyte Ratio (NLR)
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.
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
Mortality (all cause mortality and cardiovascular mortality)
Mortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
MACE (Major Acute Coronary Events)
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 .
Time frame: 6 months post-ACS with a potential prolonged period of roughly 12 months
Difference in Mean NLR Between STEMI and NSTEMI Patients
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
Time frame: At hospital admission
Association Between High NLR and Presence of Multivessel Coronary Artery Disease
This outcome explores whether elevated NLR values are associated with the presence of multivessel disease identified during coronary angiography.
Time frame: During initial coronary angiography
Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)
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.
Time frame: Within 48 hours of hospital admission
Correlation Between NLR and Peak Troponin Levels
This outcome evaluates the correlation between baseline NLR and peak troponin levels as a surrogate marker for myocardial infarction size.
Time frame: During hospitalization (within first 5 days of admission)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Nov 2024 (actual). Primary completion is estimated for Nov 2026, 24 months after the start.
Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 24 months is below that.
Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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