Clinical Characteristics, Frailty, and Prognostic Predictors in Patients Aged 75 and Older With Acute Coronary Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorClinical Center Niš

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Percutaneous Coronary Intervention (PCI)

    Procedure/Surgery

    Patients receiving PCI as part of routine clinical care

  • Conservative Medical Therapy

    Other intervention

    Patients treated conservatively with guideline-directed medical therapy as part of routine care

Treatment groups

550 Participants
are divided into 1 treatment group
Group A: Hospitalized Patients ≥75 Years With Acute Coronary Syndrome2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Peri-procedurally (within 48 hours of PCI or index admission for conservative therapy), at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).

Secondary outcomes

1

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 (%)

Time frame
Peri-procedurally (within 48 hours of PCI or index admission) and at discharge (assessed up to 14 days after admission (Day 1)).
2

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.

Time frame
6 months after discharge (± 14 days).
3

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).

Time frame
Baseline (Day 1).
4

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.

Time frame
Baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Center Niš

Lead sponsor

University of Nis

Collaborator