Assessment of Thrombotic Status in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- Thrombotic status
研究概览
简要总结
Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status
详细描述
AF affects 1 in 4 people in their lifetime. Although generally thought of as a safe heart rhythm disturbance, the risk associated with AF is through the formation of clot (thrombus) within the heart which be ejected from the heart when it contracts causing a heart attack or perhaps more devastatingly a stroke.
The mainstay of treatment for AF involves thinning the blood with drugs such as warfarin or newer drugs termed novel oral anticoagulants. In addition to this there are 3 main ways of treating the underlying rhythm disturbance:
- Accept the irregular heart rhythm and simply control the heart rate with heart rate limiting drugs such as beta blockers or digoxin in addition to the blood thinning medicines.
- Restore the normal heart rhythm with with an electrical shock termed a direct current cardioversion (DCCV). This is usually a temporary measure, indeed 70% of whom will have reverted to AF by 12 months.
- Attempt to permanently restore sinus rhythm through an atrial fibrillation ablation procedure.
The investigators study, through use of a relatively novel bedside test will examine the effects of each of these management strategies on the thrombotic status of the participant's blood.
Investigators will take blood from in total 500 participants divided between each of the above management strategies which has been decided by their parent teams (i.e. study does not affect their treatment).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Male and female patients aged 18 years or over
- •Patients diagnosed with atrial fibrillation managed in one of the 3 ways outlined above
- •The patient is willing and able to understand the Patient Information Sheet and provide informed consent
- •The patient must agree to comply with the drawing of blood samples for the assessments
排除标准
- •Male and female patients aged < 18 years of age
- •The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
- •The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
- •Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity
- •Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
- •Any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, Hb < 8 g/dl, INR > 1.4, APTT > x 2 UNL, leucocyte count < 3.5 x 109/l, neutrophil count < 1 x 109/l)
- •Currently enrolled in an investigational device or drug trial
结局指标
主要结局
Thrombotic status
时间窗: 12 months
This will be assessed using the investigator's novel bedside blood test. Each participant will have blood taken at predetermined points in time over a 12 month period. Some will have blood sampled on 3 different occasions, some on 4 occasions and the majority will have blood sampled on 5 occasions over the 12 months. The Global Thrombosis test provides information of the time taken for whole blood to clot (occlusion time) and then for the clot to naturally break down (lysis time)
次要结局
- Major adverse clinical event (MACE)(12 months)
研究者
Prof Diana Gorog
Professor of cardiology
East and North Hertfordshire NHS Trust