Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,257
- 试验地点
- 2
- 主要终点
- Change in Incidence of Atrial Fibrillation Due to Exercise
研究概览
简要总结
The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.
详细描述
The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.
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
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects already enrolled in the parent WHISH study.
- •Subjects who are at high risk of developing atrial fibrillation.
排除标准
- •Subjects who have had atrial fibrillation at baseline.
结局指标
主要结局
Change in Incidence of Atrial Fibrillation Due to Exercise
时间窗: One year
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
时间窗: One year
次要结局
未报告次要终点
研究者
Marco Perez
Associate Professor of Medicine (Cardiovascular Medicine)
Stanford University