Impact of Clinical, Echocardiographic and Biological Parameters to the Risk of Cardiovascular Disease in Patients With Non-valvular Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 825
- 试验地点
- 4
- 主要终点
- composite endpoint of all-cause death, acute heart failure, stroke, acute coronary syndrome and major bleeding episode
研究概览
简要总结
The aim of the present prospective study is to further develop and validate a composite risk score predicting both ischemic and bleeding risk, based on epidemiologic, clinical, biological, and/or morphologic complementary data. First, the investigators will assess the predictive performance of current clinical risk scores. Second, the investigators will assess the potential predictive value of additional markers. Third, the investigators will aim to develop a new risk score.
详细描述
Patients with Atrial Fibrillation (AF) have an excessive risk of arterial thromboembolic disease and heart failure, resulting in higher rates of cardiovascular and all-cause mortality in this population.
Prevalence and incidence of Non-Valvular AF (NVAF) is rapidly increasing across developed countries. cardiovascular (CV) and all-cause mortality rates related to AF have increased between 1990 and 2010, irrespective of sex.
Determinants of AF (heart disease and/or cardiovascular risk factors), are themselves associated with an excess risk of cardiovascular events.
Primary prevention of NVAF relies on the control of modifiable risk factors, such as overweight, arterial hypertension, diabetes, and tobacco consumption which are associated with the risk of AF risk and its complications.
Preventive treatment of cardiovascular complications is based on anti-thrombotic treatment, which reduces the global ischemic risk but at the expense of an increase of bleeding risk.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above 18 years of age
- •Presenting a NVAF which is paroxysmal, persistent or permanent and documented by an electrocardiogram (ECG)
- •Willing and able to give written informed consent
排除标准
- •Patients presenting a clinically and echocardiographically significant valve disease defined as :
- •mitral stenosis with a valve area < 2cm2
- •mitral insufficiency (grade 3 or 4)
- •aortic insufficiency (grade 3 or 4)
- •tricuspid insufficiency (grade 3 or 4)
- •aortic stenosis with a valve area < 1.5 cm2
- •mechanical valve prosthèses
- •Secondary AF due to an acute cause (thyrotoxicosis, acute pericarditis, infection, systemic disease)
- •Presence of a contraindication to long term anticoagulant treatment
- •Absence of social security coverage
- •Severe psychiatric history
- •Impossibility of follow-up
结局指标
主要结局
composite endpoint of all-cause death, acute heart failure, stroke, acute coronary syndrome and major bleeding episode
时间窗: two years
次要结局
- incidence of cardiovascular death(two years)
- incidence of acute heart failure(two years)
- incidence of stroke(two years)
- incidence of acute coronary syndrome(two years)
- incidence of all-cause death(two years)
- incidence of major bleeding episodes(two years)
研究者
Ariel Cohen
Head of the cardiology department
Saint Antoine University Hospital