Long-term Outcome of a Pragmatic Trial of Multifaceted Intervention (STROKE-CARD Care) to Reduce Cardiovascular Risk and Improve Quality-of-life After Ischemic Stroke and Transient Ischemic Attack
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
研究概览
简要总结
We undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. To further investigate the long-term efficacy of STROKE-CARD care all participants of the original trial will be invited for a Long-term in Person follow-up (3 - 6 years).
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
- •Inclusion in the previous STROKE-CARD trial (NCT02156778)
- •Written informed consent
排除标准
- 未提供
结局指标
主要结局
The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
时间窗: through study completion, an average of 4,5 years
Recurrent stroke
The composite CVD outcome: vascular death
时间窗: through study completion, an average of 4,5 years
death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, cardiovascular procedures, and death due to other CV causes.
The composite CVD outcome: nonfatal myocardial infarction
时间窗: through study completion, an average of 4,5 years
Major recurrent (post-discharge) cardiac event
self-reported health-related quality of life
时间窗: through study completion, an average of 4,5 years
quantified with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) overall health utility score14 with rescaled European visual analogue scale weights.
次要结局
- all-cause mortality(through study completion at long term follow up visit, an average of 4,5 years)
- The composite outcome of stroke/TIA(through study completion, an average of 4,5 years)
- EQ-ED-3L(through study completion at long term follow up visit, an average of 4,5 years)
- Proportions of participants achieving target levels of risk factors in each trial arm of the previous STROKE-CARD trial.(through study completion at long term follow up visit, an average of 4,5 years)