Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Seattle Angina Questionnaire
研究概览
简要总结
The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60 months. The study endpoints will be the improvement of angina status and quality of life as assessed by validated questionnaires at one year. All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) dietary counselling, ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv) exercise training and v) psychological intervention. Patients randomized to the control group will be managed according to current guidelines. The angina status will be assessed by the Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).
详细描述
The aim of the SAMCRO trial is to determine whether a multidomain lifestyle intervention improves angina status and quality of life in ANOCA patients as compared to current standard of care.
Patients will be randomized to:
EXPERIMENTAL ARM: MULTI-DOMAIN LIFESTILE INTERVENTION
Patients will receive five different kinds of intervention:
i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling CONTROL ARM: STANDARD OF CARE Patients randomized to the control group will be managed according to current guidelines
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
- Single (Outcomes Assessor)
盲法说明
The investigators in charge of follow-up visits and questionnaire collections will be different from investigators in charge of recruitment, baseline questionnaires collection and randomization procedure. The investigators in charge of follow-up procedures will be completely blinded to the randomization, as well as patient identifying information. Regarding clinical outcomes, an independent Clinical Event Committee (CEC) will adjudicate all endpoints. The CEC members and the CEC management team will be completely blinded to the randomization, as well as patient identifying information. Other measures to avoid or minimize bias introduced by the open-label design will include intent-to-treat principles of analysis and use of objective measures for endpoint classification.
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
- •Patient admitted to hospital for chronic coronary syndrome (CCS) with indication for coronary artery angiography
- •absence of obstructive coronary artery disease at invasive coronary artery angiography
- •Coronary microvascular dysfunction as identified by invasive coronary physiology
排除标准
- •Planned coronary revascularization
- •Co-morbidity reducing life expectancy to less than 1 year
- •Any factor precluding 1-year follow-up
- •Prior Coronary Artery Bypass Graft (CABG) surgery
- •Presence of a chronic total occlusion (CTO)
研究组 & 干预措施
STANDARD OF CARE
Patients randomized to the control group will be managed according to current guidelines
MULTI-DOMAIN LIFESTILE INTERVENTION
Patients will receive five different kinds of intervention:
i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling
干预措施: MULTI-DOMAIN LIFESTILE INTERVENTION (Other)
结局指标
主要结局
Seattle Angina Questionnaire
时间窗: 1-year
The primary efficacy endpoint is the value of Seattle Angina Questionnaire (SAQ) summary score. The SAQ-SS ranges from 0 to 100 and higher values indicate better outcome
次要结局
- Clinical adverse events(1-year)
- Beck Depression Inventory (BDI)(1-year)
- EQ visual analogue scale(1-year)