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Not yet recruiting NCT07190274

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

Observational Frailty ACS (Acute Coronary Syndrome) MACE GRACE Score

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Frailty, ACS (Acute Coronary Syndrome), MACE, GRACE Score. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 30-day Major Adverse Cardiovascular Events (MACE) [Time frame: 30 days after index admission]
Secondary outcome measures (2)
  • All-cause mortality [Time frame: 30 days after index admission]
  • Acute Kidney Injury (AKI) [Time frame: 30 days after index admission]

Eligibility criteria

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

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07190274 · frailty in ACS patients

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗