Target Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome - TIRANA (ACS) Prospective REGISTRY
Conditions: ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation, Inflammation Biomarkers, NSTEMI - Non-ST Segment Elevation MI, STEMI
Sponsor: University Hospital Centre Mother Teresa

Main-Title: Target Investigation of Residual Inflammation after Non-ST/ ST Elevation 
Acute Coronary Syndrom - TIRANA (ACS) Prospective REGISTRY 
 
Field 
 Description 
 
Study Title 
 Neutrophil/Lymphocyte Ratio as an Important Predictor of Mortality in Post-
Acute Coronary Syndrome Patients 
 
Brief 
Summary 
(max 
500 
words) 
 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:  
a) Differences in mean NLR between STEMI and NSTEMI patients. 
 
b) Association between elevated NLR and the presence of multivessel 
coronary 
artery 
disease 
on 
angiography. 
 
c) 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.  
 
Detailed 
Description 
 
 
 
Methodology: 
Objective: To evaluate the neutrophil-to-lymphocyte ratio (NLR) as a 
significant predictor of mortality in patients post-acute coronary syndrome 
(ACS). 
 
Specific Aims: 
1.To assess the correlation between the NLR and in-hospital death, as well as 
6-month 
mortality, 
in 
post-ACS 
patients. 
 
2.To determine the correlation between the NLR and the presence of 
multivessel coronary disease on angiography, as well as with PLR, C-reactive 
protein (CRP) levels, and high-density lipoprotein (HDL) cholesterol levels. 
 
3.To evaluate the correlation between the NLR and maximum troponin levels 
(as an indicator of myocardial infarction size). 
 
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. 
 
Study Type 
 Prospective observational 
Study Phase 
 Not Applicable 
Study Design 
 
 
 
Observational Model: Cohort 
Time Perspective: Prospective 
Number of Groups: 2 (STEMI and NSTEMI patients) 
 

This is a retrospective observational cohort study evaluating the prognostic 
value of the neutrophil-to-lymphocyte ratio (NLR) in predicting 6-month 
mortality in patients who underwent PCI following an acute coronary 
syndrome. 
Conditions 
 Acute Coronary Syndrome 
Interventions  Not Applicable 
Outcome 
Measures 
  
Primary Outcome  : 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 
 
Description:  
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 
Safety Issue: No 
 
Secondary Outcome   
1. Outcome Measure Title: Difference in Mean NLR Between STEMI 
and NSTEMI Patients 
Description: 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 
Safety Issue: No 
2. Outcome Measure Title: Association Between High NLR and 
Presence of Multivessel Coronary Artery Disease 
Description: 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 . 
Safety Issue: No 
3. Outcome Measure Title: Correlation Between NLR and Other 
Inflammatory Markers (PLR, CRP, HDL-Cholesterol) 
Description: 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 
Safety Issue: No 
4. Outcome Measure Title: Correlation Between NLR and Peak 
Troponin Levels 
Description: 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) 
Safety Issue: No 

 
 
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. 
Locations 
  
University Medical Center of Tirana "Mother Teresa". Planning to enroll in 
our registry also the  University Clinical Center of Kosovo. Therefore a 
bicentric prospective ACS-Registry. 
Sponsor/Colla
borators 
 None 
Responsible 
Party 
 Martiola Kola , Dr.Andi Rroku MD , Prof . Alban Dibra MD , Phd 
IRB Approval 
  
 3232