ACS (Acute Coronary Syndrome)TIRANA (ACS)NCT07026708
TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome
An observational study of ACS (Acute Coronary Syndrome) and Myocardial Infarction (MI), run by University Hospital Centre Mother Teresa at 1 site in Albania.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation
- How many people
- 1,600 participants
- Where
- 1 siteAlbania
- Study dates
- 1 Nov 2024to 1 Jun 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Albania1 site, 1 recruiting
- Recruiting
Faculty of Medicine Tirana
Tirana, 1005
Alban Dibra, Prof . Dr, PhD, +355682085837, a_dibra@yahoo.com
Martiola Kola, +355693410998, martiola.kola@gmail.com
About this study
Official title: 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.
Read more
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:
- Differences in mean NLR between STEMI and NSTEMI patients.
- Association between elevated NLR and the presence of multivessel coronary artery disease on angiography.
- 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.
- Conditions
- ACS (Acute Coronary Syndrome), Myocardial Infarction (MI), Myocardial Inflammation, Inflammation Biomarkers, NSTEMI - Non-ST Segment Elevation MI, STEMI
- Keywords
- Residual inflammation, Myocardial infarction, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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 .
Measured: 6 months post-ACS with a potential prolonged period of roughly 12 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During hospitalization (within first 5 days of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Centre Mother Teresa
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Andi Rroku, MD, Principal investigator, Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin FranklinAlban Dibra, Prof. Dr, Phd, Study director, University of Medicine, TiranaMartiola Kola, MD, Principal investigator, University of Medicine, Tirana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026708
- Sponsor's protocol ID
- 3232
- Acronym
- TIRANA (ACS)
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided