Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Inflammation
研究概览
简要总结
The main objective of the CARE-ANEURYSM project is to evaluate inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease in relation to patients with abdominal aortic aneurysm or coronary artery disease (acting as controls).
详细描述
The trial will enrol 180 patients, 60 in each of three groups: 1) aneurysmal coronary artery disease; 2) abdominal aortic aneurysm; 3) coronary artery disease. In addition, up to 250 patients with aneurysmal coronary disease will be follow for clinical outcomes in relation to controls (prognosis group).
The primary research question of this project is to evaluate wheter the inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease differ from ones in abdominal aortic aneurysm or coronary artery diseases. Study endpoints include the level of inflammation biomarkers and fibrin clot properties in each cohort.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old
- •Angiographically confirmed coronary artery ectasia or aneurysm (Arm I)
- •Abdominal aortic aneurysm (Arm II)
- •Angiographically confirmed coronary artery disease (Arm III)
排除标准
- •Less than 12 months from ACS
- •Actual oral anticoagulant therapy
- •Actual antiplatelet therapy other than aspirin
- •Heart failure NYHA IV
- •Untreated hyperthyroidism or hypothyroidism
- •Severe comorbidities
- •Lack of consent
结局指标
主要结局
Inflammation
时间窗: Baseline (at enrolment)
Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
Composite Clinical outcome after 5 years
时间窗: 5 years after the enrolment
Death, stroke, myocardial infarction
Clotting
时间窗: Baseline (at enrolment)
Fibrin clot properties (such as clot lysis time, clot permeability) in each group
Composite Clinical outcome after 1 year
时间窗: 1 year after the enrolment
Death, stroke, myocardial infarction
次要结局
未报告次要终点