Actively Recruiting

Age: 75Years +
All Genders
ID07366684

Investigation of Clinical Characteristics, Frailty, and Predictors of In-Hospital and Six-Month Prognosis in Hospitalized Patients Aged 75 Years and Older With Acute Coronary Syndrome

Led by Clinical Center Niš · Updated on 2026-05-15

550

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

C

Clinical Center Niš

Lead Sponsor

U

University of Nis

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying clinical characteristics, frailty, and factors that predict outcomes in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS). This includes both a retrospective review of about 350 patients and a prospective enrollment of around 800 patients. The goal is to see if combining frailty scores with clinical and lab data at admission can better predict risks for complications and death compared to standard risk scores like TIMI, GRACE, and Syntax. The study also compares outcomes between patients treated with percutaneous coronary intervention (PCI) and those treated with medicines alone. The study collects data from medical records for the retrospective group and enrolls new patients for the prospective group, assessing frailty within 48 hours of admission using a specific scale. Clinical tests include echocardiography and coronary angiography as per hospital protocols. Patients receive either PCI or conservative medical treatment according to routine care. They are followed during their hospital stay and for six months after discharge to assess major heart events, mortality, rehospitalizations, bleeding and neurological complications related to PCI, and treatment adherence. Participants will have their clinical, lab, heart imaging, and frailty data collected and monitored. The study uses structured forms and phone interviews to track outcomes over time. Data is carefully managed and analyzed with statistical software to identify predictors of outcomes and to validate findings between the two patient groups. Safety and adverse events are monitored following cardiology guidelines. The total follow-up period includes hospitalization and six months post-discharge to support personalized treatment approaches for elderly patients with ACS.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 75 years or older
  • Diagnosis of acute coronary syndrome (STEMI, NSTEMI, or unstable angina)
  • Hospitalization in a tertiary care center (University Clinical Center Niš)
  • Signed informed consent for prospective cohort participants
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at hospital admission

Monitoring

Duration - Up to 14 days during hospitalization

Participants are observed during their hospitalization for acute coronary syndrome, including clinical assessments, frailty evaluation within 48 hours of admission, laboratory monitoring, echocardiography, and angiography as part of routine care.

Assessments during hospital stay (up to 14 days)

Long-term Monitoring

Duration - 6 months after discharge (± 14 days)

Participants are followed for 6 months after hospital discharge to monitor health outcomes including rehospitalizations, major adverse cardiovascular events, mortality, and treatment adherence through structured case report forms and telephone interviews.

Telephone interviews and follow-up assessments over 6 months

Trial Site Locations

Total: 1 location

1

Clinical Center Niš

Niš, Serbia, 18000

Actively Recruiting

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Research Team

S

Svetlana Apostolović

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Management of Acute Coronary Syndromes in Older People: Comprehensive Review and Multidisciplinary Practice-Based Recommendations.

Ahthavan Narendren, Natalie Whitehead, Louise M Burrell...

https://pubmed.ncbi.nlm.nih.gov/39124683

Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry.

Karolina Szummer, Maria E Montez-Rath, Joakim Alfredsson...

https://pubmed.ncbi.nlm.nih.gov/32867508

Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association.

Abdulla A Damluji, Daniel E Forman, Tracy Y Wang...

https://pubmed.ncbi.nlm.nih.gov/36503287

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.

Amit Rout, Mohamad B Moumneh, Kriti Kalra...

https://pubmed.ncbi.nlm.nih.gov/39494560