NCT02401854已完成不适用
Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder Using Automatic Algorithms for AF Detection: A Pilot Study (ASSERT-III)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Occurance of atrial fibrillation episode
研究概览
简要总结
The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for inclusion if they meet all of the following:
- •Age ≥ 80 years
- •History of hypertension OR a blood pressure of ≥ 140/90 mmHg
- •Attending a primary care clinic, OR ambulatory resident of a chronic care facility
- •At least one of the following additional risk factors for developing AF:
- •Body mass index ≥ 30
- •History of smoking
- •Documented Obstructive sleep apnea
- •Cardiovascular disease
- •Heart Failure
- •Left ventricular hypertrophy (on ECG or echocardiography)
- •Provide written informed consent
排除标准
- •ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes
- •Existing implanted pacemaker or defibrillator
- •Patients considered by the investigator to be unsuitable for study follow-up because the patient:
- •is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
- •has a life expectancy less that the expected study duration due to concomitant disease
- •has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -
结局指标
主要结局
Occurance of atrial fibrillation episode
时间窗: within 30 - 60 days of follow-up
Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration
次要结局
- Proportion of patients eligible to receive anticoagulation(30 - 60 days of follow-up)
- AF Burden(30 - 60 days of follow-up)
- Tolerability and feasibility of long term monitoring in elderly patients(30 - 60 days of follow-up)
研究者
Jeff Healey
Co-Principal Investigator
Population Health Research Institute
研究点 (4)
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