Southeastern Europe Microcirculation Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 10
- 主要终点
- all-cause death and non-fatal MI
研究概览
简要总结
SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA) and to assess the regional practice of patient selection, cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.
详细描述
The study will include adults of both sexes older than 18 years with angina symptoms or angina equivalent referred to cath lab for evaluation of coronary artery disease (CAD) that underwent invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA) The study will exclude persons under the age of 18, pregnant of nursing ant the ones where no coronary physiology measurements performed
.
The following data will be collected at enrollment:
- De-identified demographic data
- Cardiovascular risk factors and significant co-morbidities
- Laboratory investigations of interest
- Prior cardiovascular events
- Pre-procedure medications
- Echocardiogram within 3 months of invasive coronary procedure
- Non-invasive ischemia testing within 3 months of invasive coronary procedure
- Seattle Angina Questionnaire (SAQ)
- EQ-5D-5L
- Details of the coronary angiography and invasive physiology procedure including procedural complications
- Post-procedure medications
Data that will be collected during invasive coronary physiology testing:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sexes older than 18 years
- •Angina symptoms or angina equivalent
- •Referred to Cath lab for evaluation of CAD
- •Invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA)
排除标准
- •Persons under the age of 18
- •Pregnant of nursing
- •No coronary physiology measurements performed
结局指标
主要结局
all-cause death and non-fatal MI
时间窗: 5 years
The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure
composite MACE
时间窗: 5 years
The study will record aggregate number of participants that died from any cause and/or experienced non-fatal myocardial infarction and/or coronary angioplasty procedure and/or hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography)
次要结局
- repeated coronary angiography(5 years)
- all-cause death(5 years)
- cardiovascular death(5 years)
- myocardial infarction(5 years)
- coronary revascularization(5 years)
- stroke(5 years)
- hospitalization for acute coronary syndrome(5 years)
- hospitalization for heart failure(5 years)
研究者
Ivan Ilić, MD, PhD
Assistant Professor
Institute for Cardiovascular Diseases "Dedinje"