Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 405
- 试验地点
- 5
- 主要终点
- Number of Participants with New Atrial fibrillation
研究概览
简要总结
The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.
详细描述
Atrial fibrillation (AF) and hypertension are among the main treatable risk factors for ischemic stroke and transient ischemic attack (TIA). Detecting paroxysmal atrial fibrillation in stroke patients is challenging, but highly relevant since anticoagulation can effectively reduce the risk of recurrent strokes. Furthermore, hypertension remains poorly controlled even after stroke despite multiple available treatment options. In the CARDIOSTROKE trial, the investigators aim to randomize 405 patients with recent ischemic stroke or TIA into (1) standard diagnostic work-up, follow-up and treatment (control group) and (2) 3-week ECG monitoring to detect occult AF and self-monitoring of blood pressure with mobile-device-assisted self-titration of antihypertensive medication (intervention group). Randomization will occur 2:1 into control and intervention groups. The co-primary outcomes include (1) incidence of new-onset AF and (2) difference in the mean blood pressure at 12-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical endpoints will be assessed according to PROBE principles, i.e. outcomes assessors are masked to treatment allocation.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke or transient ischemic attack (ABCD2 score ≥3)
- •Age ≥40 years
- •Pre-existing or newly diagnosed hypertension
- •Informed consent from the patient or legal representative
排除标准
- •Known high-risk source of cardioembolism
- •Known indication for anticoagulation
- •Contraindication for anticoagulation
- •Pacemaker
- •Non-compliance to study interventions as judged by the investigator
- •Serious condition hampering the study conduct
结局指标
主要结局
Number of Participants with New Atrial fibrillation
时间窗: 12 months
New diagnosis of atrial fibrillation (\>30 s)
Change in Blood Pressure
时间窗: 12 months
Mean change in systolic/diastolic blood pressure
次要结局
- Health Care Costs(36 months)
- Number of Participants with New Cardiovascular Events within 12 Months(12 months)
- Number of Participants with New Cardiovascular Events within 36 Months(36 months)
研究者
Jukka Putaala
Head of Stroke Unit
Hospital District of Helsinki and Uusimaa