Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 509
- 试验地点
- 2
- 主要终点
- Adherence to physical exercise
研究概览
简要总结
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program
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)
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
- •Signed informed consent
- •Equal or older 18 years old
- •Acute coronary syndrome with or without ST elevation within last two months
- •Being able to do physical exercise
- •Being able to understand the educative sessions
- •Being able to understand patient information in the consent form
排除标准
- •Hemodynamic instability
- •Left ventricular ejection fraction (LVEF) < or = 35%
- •Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
- •Refractory angina
- •Any pathology for which physical exercise is not indicated
研究组 & 干预措施
Intensivo
intensive cardiac rehabilitation program in less time
干预措施: Intensive cardiac rehabilitation program in less time (Other)
Convencional
standard cardiac rehabilitation program
结局指标
主要结局
Adherence to physical exercise
时间窗: baseline-12 months
Assessed in Metabolic Equivalents of Task (METS) from baseline by ergometry
Adherence to Mediterranean diet
时间窗: baseline-12 months
Assessed by Mediterranean diet adherence questionnaire (Modified Trichopoulou A,)
Tabacco abstinence
时间窗: baseline-12 months
Assessed by cooximetry (less dan 10 ppm)
Number of participants reporting compliance with prescribed treatments
时间窗: baseline-12 months
Patient-reported answers form the investigator
次要结局
未报告次要终点
研究者
Almudena Castro Conde
MD, PhD, Cardiology Department Staff, Hospital Universitario La Paz , Madrid
Spanish Society of Cardiology