Role of Frailty in Bleeding Risk Prediction in Acute Coronary Syndrome

NCT ID: NCT07158788

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 850 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-09-01

Brief Summary

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.

Conditions

Frailty; Acute Coronary Syndrome; Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. - Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment

2. - Patients must be older than 65 years

Exclusion Criteria

1. - Patients younger than 65 years

2. - Refusal of participation

3. - In - hospital death unrelated to bleeding

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mario Hosny Labib Habib

Resident physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Frailty Bleeding ACS

Identifier Type: -

Identifier Source: org_study_id