Incremental Value of Frailty Indices in Bleeding Risk Prediction Among Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 850
- 主要终点
- Bleeding Academic Research Consortium ( BARC ) type 3 to 5
研究概览
简要总结
Studying the incremental role of frailty in predicting in-hospital, short-term (30 days), and mid-term (6 months) bleeding in ACS patients.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment
- •- Patients must be older than 65 years
排除标准
- •- Patients younger than 65 years
- •- Refusal of participation
- •- In - hospital death unrelated to bleeding
结局指标
主要结局
Bleeding Academic Research Consortium ( BARC ) type 3 to 5
时间窗: 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)
次要结局
- Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2(Baseline)
研究者
Mario Hosny Labib Habib
Resident physician
Assiut University