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Not yet recruiting NCT07158788

Role of Frailty in Bleeding Risk Prediction in Acute Coronary Syndrome

Observational Frailty Acute Coronary Syndrome Bleeding

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, Acute Coronary Syndrome, Bleeding. 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

Incremental Value of Frailty Indices in Bleeding Risk Prediction Among Patients With Acute Coronary Syndrome

Overview

Studying the incremental role of frailty in predicting in-hospital, short-term (30 days), and mid-term (6 months) bleeding in ACS patients.

Detailed description

Potent platelet inhibition reduces the risk of thrombotic complications in patients with acute coronary syndromes. Unavoidably, the more potent platelet inhibition increases the risk of bleeding. Bleeding risk can be predicted using the ARC-HBR criteria, the CRUSADE score, ACUITY score, and PRECISE-DAPT score. These conventional risk scores incorporate clinical, laboratory and procedural variables but often overlook patient centered geriatric parameters such as frailty. Frailty is a multidimensional syndrome characterized by decreased reserves and diminished resistance to stressors. It can be assessed using Rockwoods clinical frailty scale, the frailty index, frailty domains and the Fried scale. The association between frailty and bleeding risk in ACS patients is still inadequately studied. We hypothesize that frailty indices would increase the discriminatory power of established standard bleeding risk scores, and would predict bleeding events among ACS patients.

Primary outcome measures

  • Bleeding Academic Research Consortium ( BARC ) type 3 to 5 [Time frame: Baseline]
Secondary outcome measures (1)
  • Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2 [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • \- Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment
  • \- Patients must be older than 65 years

Exclusion criteria

  • \- Patients younger than 65 years
  • \- Refusal of participation
  • \- In - hospital death unrelated to bleeding

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: NCT07158788 · Frailty Bleeding ACS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗