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

Official title

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

Overview

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.

Detailed description

This observational study will evaluate clinical characteristics,frailty, and prognostic predictors in patients aged 75 years and older hospitalized with acute coronary syndrome (ACS). The study is designed with two complementary components:

Retrospective cohort (≈350 patients):

Data will be collected from electronic medical records of patients previously hospitalized with ACS. Variables include demographics, comorbidities, laboratory findings (hematology, biochemistry, cardiac biomarkers), ECG changes, echocardiographic parameters, and coronary angiography results. Standard risk scores (TIMI, GRACE, Syntax) will be compared with observed outcomes. Data integrity will be ensured through double-entry verification, and missing values will be addressed using multiple imputation.

Prospective cohort (≈800 patients):

Patients will be consecutively enrolled at admission with ACS. Data collection will include the same parameters as in the retrospective cohort, with additional dynamic laboratory monitoring and frailty assesment. Frailty will be assessed within 48 hours of admission using the Rockwood Frailty Scale, performed by trained investigators. Echocardiography and coronary angiography will be conducted according to institutional protocols. Patients will be followed during hospitalization and 6 months after discharge, using structured case report forms and telephone interviews. Outcomes will include major adverse cardiovascular events (MACE), all-cause mortality, rehospitalizations, PCI-related complications (vascular, gastrointestinal bleeding, neurological), and treatment adherence.

Data management and statistical analysis:

All data will be entered into a secure, password-protected database with regular quality control checks. Statistical analyses will be performed using SPSS v.27 and R. Methods include descriptive statistics, univariate and multivariate logistic regression, ROC curve analysis, and comparison of AUC values. Predictors identified in the retrospective cohort will be validated in the prospective cohort.

The study team consists of cardiologists, statisticians, and trained research staff responsible for patient enrollment, frailty assessment, and data monitoring. Complications and adverse events will be defined according to standardized cardiology guidelines and adjudicated by an independent committee.

The study is conducted in accordance with the Declaration of Helsinki. Retrospective data collection does not require informed consent, while prospective participants will provide written informed consent. The expected contribution is improved risk stratification and more personalized therapeutic approaches for elderly patients with ACS.

Interventions

• Procedure Percutaneous Coronary Intervention (PCI)
  Patients receiving PCI as part of routine clinical care
• Other Conservative Medical Therapy
  Patients treated conservatively with guideline-directed medical therapy as part of routine care

Primary outcome measures

• 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) [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 outcome measures (12)

• Impact of treatment strategy (PCI vs conservative therapy) on hemorrhagic complications [Time frame: 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 [Time frame: 6 months after discharge (± 14 days).]
• Demographic predictors of conservative management [Time frame: Baseline (Day 1).]
• Admission hemoglobin as predictor of conservative management [Time frame: Baseline.]
• Admission eGFR (CKD-EPI) as predictor of conservative management [Time frame: Baseline.]
• Admission hs-Troponin I as predictor of conservative management [Time frame: Baseline.]
• Admission CRP as predictor of conservative management [Time frame: Baseline.]
• Admission BNP/NT-proBNP as predictor of conservative management [Time frame: Baseline.]
• Admission HbA1c as predictor of conservative management [Time frame: Baseline.]
• Composite admission laboratory abnormality score as predictor of conservative management [Time frame: Baseline.]
• ECG ischemic changes at admission as predictor of conservative management [Time frame: Baseline]
• ECG rhythm and arrhythmias at admission as predictor of conservative management [Time frame: Baseline.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Serbia · 1 center

• Clinical Center Niš — Niš

Publications

• 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
• 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
• 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
• 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
• 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
• 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 PMID 36503287
• 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.124.0361 PMID 39494560

Identifiers

NCT: NCT07366684 · ACS75-NIS-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗