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Prospective Observational Cohort Study on Impact of Frailty on Risk Prediction, Treatment Strategies, and Short-Term Outcomes in Patients With Acute Coronary Syndrome

Impact of Frailty on Risk Prediction, Treatment Strategies, and Short-Term Outcomes in Patients With Acute Coronary Syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07190274
Enrollment
645
Registered
2025-09-24
Start date
2025-12-01
Completion date
2028-06-01
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACS (Acute Coronary Syndrome), Frailty, GRACE Score, MACE

Keywords

frailty, ACS

Brief summary

we aim : * To evaluate how frailty influences acute management decisions (invasive vs conservative strategy) in ACS patients and whether it independently affects short-term outcomes. * To determine whether adding frailty assessment to existing ACS risk prediction models improves the prediction of 30-day mortality and major adverse cardiovascular events (MACE) in elderly ACS patients.

Detailed description

Frailty is a geriatric syndrome used to define elderly patients with impaired resistance to stressors due to a decline in physiological reserve. Frailty has become increasingly relevant in the field of cardiovascular medicine, not only for the increased aging of the population, but also for the emerging evidence linking CVD and frailty both at the mechanistic level and the epidemiologic level. The elderly represent an increasing proportion of ACS patients, but they are often excluded from or underrepresented in clinical trials. A thorough assessment of older ACS patients is important, including the evaluation of frailty or comorbidity from the onset of hospitalization and extending to intervention, medications, and type and frequency of MACE. This strategy enables the delivery of a personalized approach for such a vulnerable subgroup. While established ACS risk models like the GRACE and TIMI scores guide treatment decisions and predict outcomes, they do not account for frailty, an independent, multidimensional predictor of adverse events in the elderly. Evaluating both the predictive value of frailty and its effect on treatment decisions and outcomes provides comprehensive insight into its clinical relevance in ACS.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elderly: Age ≥65 years . * STEMI/NSTEMI (ESC/ACC criteria) * Presentation \<24h of symptom onset

Exclusion criteria

* Terminal illness (life expectancy \<1 month) * Severe dementia precluding assessment * Declined consent

Design outcomes

Primary

MeasureTime frameDescription
30-day Major Adverse Cardiovascular Events (MACE)30 days after index admissionComposite outcome including cardiovascular death, non-fatal myocardial infarction, stroke, or urgent revascularization, stratified by frailty status.

Secondary

MeasureTime frameDescription
All-cause mortality30 days after index admissionMortality occurring during index hospitalization
Acute Kidney Injury (AKI)30 days after index admissionAKI defined according to KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days).

Contacts

Primary ContactFady Gamal Habib
fady.17289635@med.aun.edu.eg+201004721578
Backup ContactAhmed Abdelgaleel
Ahmed.galeel@aun.edu.eg+201005015156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026