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

September 27, 2025 updated by: University Hospital Centre Mother Teresa

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Albania
      • Tirana, Albania, 1005
        • Recruiting
        • Faculty of Medicine Tirana
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martiola Kola
        • Principal Investigator:
          • Andi Rroku, MD
        • Principal Investigator:
          • Alban Dibra, Prof. Dr, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute Coronary Syndrome Patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil-to-Lymphocyte Ratio (NLR)
Time Frame: 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.
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
Mortality (all cause mortality and cardiovascular mortality) in Post-Acute Coronary Syndrome (ACS) Patients .
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
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 .
6 months post-ACS with a potential prolonged period of roughly 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Mean NLR Between STEMI and NSTEMI Patients
Time Frame: At hospital admission

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
At hospital admission
Association Between High NLR and Presence of Multivessel Coronary Artery Disease
Time Frame: During initial coronary angiography
This outcome explores whether elevated NLR values are associated with the presence of multivessel disease identified during coronary angiography.
During initial coronary angiography
Correlation Between NLR and Other Inflammatory Markers (PLR, CRP, HDL-Cholesterol)
Time Frame: Within 48 hours of hospital admission
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.
Within 48 hours of hospital admission
Correlation Between NLR and Peak Troponin Levels
Time Frame: During hospitalization (within first 5 days of admission)
This outcome evaluates the correlation between baseline NLR and peak troponin levels as a surrogate marker for myocardial infarction size.
During hospitalization (within first 5 days of admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Centre Mother Teresa

Collaborators

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Andi Rroku, MD, Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
  • Study Director: Alban Dibra, Prof. Dr, Phd, University of Medicine, Tirana
  • Principal Investigator: Martiola Kola, MD, University of Medicine, Tirana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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