Role of Frailty in Bleeding Risk Prediction in Acute Coronary Syndrome

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07158788

Enrollment

850

Registered

2025-09-08

Start date

2025-10-01

Completion date

2027-09-01

Last updated

2025-09-08

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

Conditions

Acute Coronary Syndrome, Bleeding, Frailty

Keywords

Frailty, acute coronary syndrome, bleeding, bleeding risk prediction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bleeding Academic Research Consortium ( BARC ) type 3 to 5	Baseline	Type 3: Major bleeding (with subtypes) 3a: Overt bleeding plus hemoglobin drop of 3-5 g/dL, or Transfusion with ≤2 units of blood. 3b: Hemoglobin drop ≥5 g/dL, Cardiac tamponade, Bleeding requiring surgical intervention, or Bleeding requiring intravenous vasoactive agents. 3c: Intracranial hemorrhage (excluding microbleeds), Intraocular bleeding compromising vision. Type 4: CABG-related bleeding Perioperative bleeding within 48 hours of coronary artery bypass grafting (CABG) and Reoperation for bleeding, ≥5 units of blood transfused, Chest tube output ≥2 L in 24 hours, or Cardiac tamponade. Type 5: Fatal bleeding 5a: Probable fatal bleeding (no autopsy or imaging confirmation). 5b: Definite fatal bleeding (confirmed by autopsy or imaging)

Secondary

Measure	Time frame	Description
Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2	Baseline	Type 0 : no bleeding Type 1: Bleeding that is not actionable and does not require medical attention Type 2 : Any bleeding that requires medical attention, hospitalization, or evaluation by a health care professional. but does not meet criteria for type 3, 4 or 5.

Outcome results