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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal to provide informed consent (prospective cohort)
- •Missing or incomplete medical documentation (retrospective cohort)
研究组 & 干预措施
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.
干预措施: Percutaneous Coronary Intervention (PCI) (Procedure)
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.
干预措施: Conservative Medical Therapy (Other)
结局指标
主要结局
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)
时间窗: 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).
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.
次要结局
- 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.)
- Admission hs-Troponin I as predictor of conservative management(Baseline.)
- Admission CRP as predictor of conservative management(Baseline.)
- Admission BNP/NT-proBNP as predictor of conservative management(Baseline.)
- Admission HbA1c as predictor of conservative management(Baseline.)
- Composite admission laboratory abnormality score as predictor of conservative management(Baseline.)
- ECG ischemic changes at admission as predictor of conservative management(Baseline)
- ECG rhythm and arrhythmias at admission as predictor of conservative management(Baseline.)
- ECG conduction abnormalities at admission as predictor of conservative management(Baseline)
- Angiographic high-risk anatomy composite as predictor of conservative management(Peri-procedurally (immediately after angiography); values used are those available at or prior to the documented treatment decision (decision documented within 48 hours of admission).)
- Left Ventricular Ejection Fraction as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- E/e' ratio as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- Pericardial effusion as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- Left Atrial Volume Index as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- Wall Motion Score Index as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- Valvular regurgitation as predictor of conservative management(At admission (transthoracic echo within 72 hours of admission), values used are those available at or prior to the documented treatment decision.)
- Comorbidity predictors of conservative management(At admission (baseline, pre-intervention/decision).)
- Frailty predictors of conservative management(At admission (baseline, pre-intervention/decision).)
- Number of Participants with Major Adverse Cardiovascular Events (MACE)(Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).)
- Number of Participants with Cardiovascular Rehospitalization(Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).)
- Number of Participants with All-cause Mortality(Outcome assessed at discharge (up to 14 days after admission (Day 1)), and outcomes reassessed 6 months after discharge (± 14 days).)
- Correlation between clinical predictors and clinical outcomes (in-hospital MACE and 6-month all-cause mortality)(Predictors measured at admission (baseline). In-hospital MACE assessed during hospitalization (up to 15 days after admission). Six-month all-cause mortality assessed 6 months after discharge (±14 days).)
- Correlation between frailty scores and cognitive categories and clinical outcomes (in-hospital MACE and 6-month all-cause mortality).(Scores measured at admission, outcomes assessed at discharge (up to 14 days after admission), and outcomes reassessed 6 months after discharge (± 14 days).)
- Secondary complications and adverse events(Peri-procedurally, at discharge (assessed up to 14 days after admission (Day 1)), and at 6 months after discharge (± 14 days).)
研究者
Svetlana Apostolović
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
Clinical Center Niš