Phase 1 Study - Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System improVement in Patients After MI With or Without hypErtension After Cardiovascular Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Arterial stiffness - Pulse wave velocity (PWV)
研究概览
简要总结
Myocardial infarction is related with endothelial function, arterial stiffness and autonomic nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is also related with endothelial function, arterial stiffness and autonomic nervous system dysfunction.
Primary aim of study is to investigate how complex cardiac rehabilitation influence endothelial function, arterial stiffness and autonomic nervous system activity according to presence or absence arterial hypertension.
Secondary aim is to obtain correlation between methods for the assessment of particular disorders and intercorrelation between different disorders for example endothelial function and autonomic nervous system activity.
详细描述
We expect that in study groups PWV will improve better that in control group. 5% of the limit value of p <0.05.
We expect that in study groups AASI will improve better that in control group. 5% of the limit value of p <0.05.
We expect that in study groups AI will improve better that in control group. 5% of the limit value of p <0.05.
We expect that time and frequency parameters of HRV will increase in study group. 5% of the limit value of p <0.05.
We expect that parameters of HRT will improve in study group. 5% of the limit value of p <0.05.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •after a recent troponin-positive acute coronary syndrome (within 7-30 days) treated by means of primary coronary angioplasty,
- •age 20-85 year old,
- •accepted and sign informed consent,
排除标准
- •unstable coronary artery disease,
- •indications for a coronary artery bypass graft (CABG),
- •peripheral artery disease,
- •uncontrolled arterial hypertension,
- •ventricular and supraventricular arrhythmias in excess of 10% of all the evolutions throughout the day,
- •allergy to latex,
- •deformities or condition after the amputation of fingers,
- •body mass index (BMI) above 35 kg/m2,
- •a significant hepatic or renal failure,
- •infectious disease.
结局指标
主要结局
Arterial stiffness - Pulse wave velocity (PWV)
时间窗: 24 month
Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.
Arterial stiffness - Ambulatory arterial stiffness index (AASI)
时间窗: 24 month
AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring.
Arterial stiffness - Augmentation index (AI)
时间窗: 24 month
AI will be calculated by EndoPAT2000 system.
次要结局
- Heart rate variability (HRV)(24 month)
- Heart rate turbulence (HRT)(24 month)
研究者
Urszula Cieslik-Guerra
M.D.
Medical University of Lodz