About this trial
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). The research includes both a retrospective and a prospective cohort. The aim is to determine whether frailty scores, combined with clinical and laboratory parameters available at admission, can improve risk prediction for complications and mortality compared with standard risk scores (TIMI, GRACE, Syntax). The study will also compare outcomes between patients treated with percutaneous coronary intervention (PCI) and those treated conservatively with medications. Patients will be followed during hospitalization and for six months after discharge. The results are expected to contribute to more personalized treatment strategies for elderly patients with ACS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years
Diagnosis of acute coronary syndrome (STEMI, NSTEMI, or unstable angina)
Hospitalization in a tertiary care center (University Clinical Center Niš)
For prospective cohort: signed informed consent
Disqualifiers
Refusal to provide informed consent (prospective cohort)
Missing or incomplete medical documentation (retrospective cohort)
Trial population
Hospitalized patients aged 75 years and older with acute coronary syndrome (STEMI, NSTEMI, unstable angina) treated at the University Clinical Center Niš. Approximately 350 retrospective and 200 prospective patients are expected to be included.
Trial design
Cohort
Other
Treatments tested in this trial
Percutaneous Coronary Intervention (PCI)
Procedure/SurgeryPatients receiving PCI as part of routine clinical care
Conservative Medical Therapy
Other interventionPatients treated conservatively with guideline-directed medical therapy as part of routine care
Treatment groups
Trial outcomes
Primary outcomes
Impact of treatment strategy (PCI vs conservative therapy) on on all-cause mortality and major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke) in elderly patients with acute coronary syndrome (ACS)
To compare outcomes of patients aged ≥75 years with ACS (STEMI, NSTEMI, unstable angina) treated with percutaneous coronary intervention (PCI) versus conservative medical therapy. The primary outcome includes all-cause mortality and major adverse cardiovascular events (MACE). Unit of Measure: % of patients experiencing event.
Secondary outcomes
Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications
Incidence of major bleeding, defined as clinically overt bleeding resulting in hemodynamic compromise, intracranial hemorrhage, bleeding requiring transfusion, or bleeding requiring surgical or endovascular hemostatic intervention; includes gastrointestinal and access-site bleeding. Unit of Measure: Incidence (%)
Number of Participants with ≥1 All-cause Rehospitalization
Proportion of patients with ≥1 rehospitalization for any cause and total number of rehospitalizations per patient during follow-up; comparison between PCI and conservative therapy. Unit of Measure: % of patients with ≥1 rehospitalization; count per patient.
Demographic predictors of conservative management
Patient age and sex as predictors of the decision to pursue conservative medical therapy instead of percutaneous coronary intervention (PCI). Independent predictors will be identified using multivariable logistic regression and reported as odds ratios with 95% confidence intervals. Measure: Age (years); Sex (male/female).
Admission hemoglobin as predictor of conservative management
Hemoglobin concentration measured at admission and recorded in the dataset. Evaluated as a predictor of conservative therapy versus PCI using multivariable logistic regression. Unit of Measure: g/L.
Sponsors and contacts
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Clinical Center Niš
Lead sponsor
University of Nis
Collaborator