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NCT Number: NCT07190274

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 30-day Major Adverse Cardiovascular Events (MACE)

    Time frame: 30 days after index admission

    Composite outcome including cardiovascular death, non-fatal myocardial infarction, stroke, or urgent revascularization, stratified by frailty status.

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days after index admission

    Mortality occurring during index hospitalization

  2. Acute Kidney Injury (AKI)

    Time frame: 30 days after index admission

    AKI defined according to KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abdelgaleel

CONTACT

[email protected]

+201005015156

Fady Gamal Habib

CONTACT

[email protected]

+201004721578

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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