NCT07026708 TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome
| NCT ID | NCT07026708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Centre Mother Teresa |
| Condition | ACS (Acute Coronary Syndrome) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2024-11-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
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.
Contact & Investigator
Andi Rroku, MD
PRINCIPAL INVESTIGATOR
Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
Frequently Asked Questions
Who can join the NCT07026708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying ACS (Acute Coronary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07026708 currently recruiting?
Yes, NCT07026708 is actively recruiting participants. Contact the research team at martiola.kola@gmail.com for enrollment information.
Where is the NCT07026708 trial being conducted?
This trial is being conducted at Tirana, Albania.
Who is sponsoring the NCT07026708 clinical trial?
NCT07026708 is sponsored by University Hospital Centre Mother Teresa. The principal investigator is Andi Rroku, MD at Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin. The trial plans to enroll 1,600 participants.