Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Evidence of definite myocardial ischemia confirmed by Holter monitoring
研究概览
简要总结
Major sporting events may have adverse cardiovascular effects in subjects with coronary heart disease. We also hypothesized that the adverse cardiovascular effects of sporting events are a result of psychobiological processes including stress-induced hemodynamic changes, autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic responses, all of which may in turn promote myocardial ischemia.
详细描述
Observational studies suggest that exposure to sporting events may worsen symptoms of angina and trigger acute myocardial infarction. The mechanisms for this association are unknown. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of sporting events.
In a randomized crossover controlled study, 38 patients with prior myocardial infarction will be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography, and blood pressure change will be analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Previous myocardial infarction (>6 months previously)treated by coronary revascularization
- •On standard secondary preventative therapy
排除标准
- •Angina pectoris (Canadian Cardiovascular Society grade ≥2)
- •History of arrhythmia
- •Uncontrolled hypertension
- •Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
- •Occupational exposure to sporting events
- •Hepatic or renal failure
结局指标
主要结局
Evidence of definite myocardial ischemia confirmed by Holter monitoring
时间窗: 2 months
Blood pressure measured by ambulatory blood pressure monitoring
时间窗: 2 months
Heart rate variability
时间窗: 2 months
次要结局
- Episode of angina(3 months)
- Episode of neurological events(3 months)
- Episode of arrhythmia(3 months)