Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients with Coronary Microvascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months
研究概览
简要总结
Exercise CMD is a prospective single-center, open-label, parallel arms randomized controlled trial.
This trial aims to assess the impact of cardiac rehabilitation on top of optimal medical therapy on patient-reported outcomes in subjects with coronary microvascular disease and non-obstructive coronary artery disease.
Patients will undergo a microvascular assessment using bolus thermodilution techniques and those with criteria for microvascular angina (IMR ≥ 25) will be invited to participate.
Patients will be randomized in a 1:1 ratio to either optimal medical therapy (OMT) or OMT plus a program of cardiac rehabilitations (CR).
After randomization, spiro-ergometry and a SAQ-19 will be performed in all patients. Medical therapy will be standardized in both arms and the CR group will follow 36 sessions of the personalized physical training program of cardiac rehabilitation.
Approximately 204 subjects (102 in each group) will be included at one site (OLV Aalst, Belgium).
Clinical Follow-Up will be planned at 4 months. Patients with CCTA performed in standard of care will be invited for control CCTA 6 +/- 1 month after the invasive procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)
- •Angina at presentation
- •Evidence of microvascular dysfunction (IMR ≥ 25)
排除标准
- •Inability to give consent
- •Acute coronary syndrome (ACS)
- •Severe valve disease
- •Permanent AF
- •History of coronary artery bypass grafting (CABG)
- •Cardiomyopathies
- •Intolerance to adenosine
- •Hemodynamic instability
- •Not able to exercise
结局指标
主要结局
Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months
时间窗: 4 Months
Mean change in health-related quality of life questionnaire as assessed by the Seattle Angina Questionnaire 19, between baseline and 4 months (SAQ-19 Summary Score) with a maximum score of 100 representing a good quality of life.
次要结局
- Mean change in VO2 peak between baseline and 4 months(4 Months)
- Mean change in VE/VCO2 slope between baseline and 4 months(4 Months)
- Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months(4 Months)
- Mean change in METS between baseline and 4 months(4 Months)
- Mean change in health related quality of life assessed by the EuroQoL 5 dimensions - 5 levels (EQ5D-5L) Questionnaire between baseline and 4 months(4 Months)
- Mean change in vessel volume between patients randomized to exercise and controls(6 Months)