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

NCT07366684 | Not Yet Recruiting

• 1 other identifier: ACS75-NIS-2025
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST Elevation (STEMI) Myocardial Infarction; Unstable Angina Pectoris; Non ST Elevation Myocardial Infarction (NSTEMI)

Keywords

Acute Coronary Syndrome (ACS); Elderly; Frailty; Percutaneous Coronary Intervention (PCI); Conservative Treatment; Major adverse cardiovascular events (MACE); Prognostic Predictors / Risk Stratification

Outcome Measures

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.

  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 (28)

• Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications

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

• Number of Participants with ≥1 All-cause Rehospitalization

  6 months after discharge (± 14 days).

• Demographic predictors of conservative management

  Baseline (Day 1).

• Admission hemoglobin as predictor of conservative management

  Baseline.

• Admission eGFR (CKD-EPI) as predictor of conservative management

  Baseline.

Study Arms (1)

Hospitalized Patients ≥75 Years With Acute Coronary Syndrome

Patients aged 75 years and older admitted with acute coronary syndrome (STEMI, NSTEMI, or unstable angina). Data will be collected retrospectively and prospectively, including clinical, laboratory, echocardiographic, angiographic, and frailty parameters. Outcomes will be assessed during hospitalization and at 6 months after discharge.

Procedure: Percutaneous Coronary Intervention (PCI); Other: Conservative Medical Therapy

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

Patients receiving PCI as part of routine clinical care

Hospitalized Patients ≥75 Years With Acute Coronary Syndrome

Conservative Medical Therapy OTHER

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

Hospitalized Patients ≥75 Years With Acute Coronary Syndrome

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to provide informed consent (prospective cohort)
• Missing or incomplete medical documentation (retrospective cohort)

Sponsors & Collaborators

• Clinical Center Niš: lead
• University of Nis: collaborator

Study Sites (1)

Clinical Center Niš

Niš, 18000, Serbia

Location

Related Publications (7)

• Narendren A, Whitehead N, Burrell LM, Yudi MB, Yeoh J, Jones N, Weinberg L, Miles LF, Lim HS, Clark DJ, Al-Fiadh A, Farouque O, Koshy AN. Management of Acute Coronary Syndromes in Older People: Comprehensive Review and Multidisciplinary Practice-Based Recommendations. J Clin Med. 2024 Jul 28;13(15):4416. doi: 10.3390/jcm13154416.

  PMID: 39124683 BACKGROUND

• Morici N, De Servi S, De Luca L, Crimi G, Montalto C, De Rosa R, De Luca G, Rubboli A, Valgimigli M, Savonitto S. Management of acute coronary syndromes in older adults. Eur Heart J. 2022 Apr 19;43(16):1542-1553. doi: 10.1093/eurheartj/ehab391.

  PMID: 34347065 BACKGROUND

• H Ratcovich, P Palm, J Faerch, L Bang, T Engstroem, H H Tilsted, L Holmvang, Prevalence and prognosis of frailty in patients >70 years old with acute coronary syndrome referred to invasive angiography. Eur Heart J Acute Cardiovasc Care. 2023;12(Suppl 1):zuad036.045. doi:10.1093/ehjacc/zuad036.045

  BACKGROUND

• Szummer K, Montez-Rath ME, Alfredsson J, Erlinge D, Lindahl B, Hofmann R, Ravn-Fischer A, Svensson P, Jernberg T. Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry. Circulation. 2020 Nov 3;142(18):1700-1708. doi: 10.1161/CIRCULATIONAHA.120.050645. Epub 2020 Sep 1.

  PMID: 32867508 BACKGROUND

• Aranzulla TC, Radano I, Civera S, Musumeci G. Acute coronary syndrome in elderly and frail patients. European Society of Cardiology - Council for Cardiology Practice, CardioPractice. Published August 6, 2024. Available at: https://www.escardio.org/Councils/Council-for-Cardiology-Practice-%28CCP%29/Cardiopractice/acute-coronary-syndrome-in-elderly-and-frail-patients

  BACKGROUND

• Damluji AA, Forman DE, Wang TY, Chikwe J, Kunadian V, Rich MW, Young BA, Page RL 2nd, DeVon HA, Alexander KP; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association. Circulation. 2023 Jan 17;147(3):e32-e62. doi: 10.1161/CIR.0000000000001112. Epub 2022 Dec 12.

  PMID: 36503287 BACKGROUND

• Rout A, Moumneh MB, Kalra K, Singh S, Garg A, Kunadian V, Biscaglia S, Alkhouli MA, Rymer JA, Batchelor WB, Nanna MG, Damluji AA. Invasive Versus Conservative Strategy in Older Adults >/=75 Years of Age With Non-ST-segment-Elevation Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2024 Nov 5;13(21):e036151. doi: 10.1161/JAHA.124.036151. Epub 2024 Nov 4.

  PMID: 39494560 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Acute Coronary Syndrome; Frailty

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Svetlana Apostolović

CONTACT

+381631094144; drapostolovic@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine, Head of the Department of Internal Medicine, Faculty of Medicine, University of Niš; Cardiologist at the Institute for Cardiology, Clinical Center Niš

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available after publication of the main results and will remain accessible for 5 years.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or healthcare institutions for non-commercial scientific purposes. Requests must include a research proposal and data use agreement.

Locations

SE (1)