Role of Frailty in Bleeding Risk Prediction in Acute Coronary Syndrome

NCT07158788 | Not Yet Recruiting

• 1 other identifier: Frailty Bleeding ACS
• Study Type: observational
• Target: 850
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Acute Coronary Syndrome; Bleeding

Keywords

Frailty; acute coronary syndrome; bleeding; bleeding risk prediction

Outcome Measures

Primary Outcomes (1)

• Bleeding Academic Research Consortium ( BARC ) type 3 to 5

  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)

  Baseline

Secondary Outcomes (1)

• Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2

  Baseline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with acute coronary syndrome ( STEMI and NSTEMI) and are older than 65 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Frailty; Acute Coronary Syndrome; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09