Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- investigate the prevalence of INOCA in women vs. men
研究概览
简要总结
Prospective, interventional, multicentre, non-randomized, single-arm open-label study that aims to enroll 200 consecutive patients with suspected chronic ischemic heart disease in the absence of obstructive coronary artery disease (INOCA) at clinically indicated coronary angiography in 3 Italian centers.
During coronary angiography, these patients will be simultaneously subjected to a functional and coronary physiology study (according to the methods reported below):
- Functional evaluation with fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of angiographic stenosis> 50%;
- In the presence of coronary angiographic stenosis <50% or> 50% but in the presence of a negative functional assessment (FFR> 0.80 and iFR / RFR> 0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be measured. IMR and CFR will be assessed using intra-coronary guidance;
- In the presence of CFR> 2.0 and IMR <25, tests with acetylcholine will also be performed in order to evaluate the possible presence of epicardial (focal or diffuse) or microvascular spasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical presentation of chronic ischemic heart disease (IHD), requiring coronary angiography for the diagnosis
- •Absence of obstructive CAD at coronary angiography
- •Age > 18 years
- •Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation
排除标准
- •Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock
- •Presence of obstructive CAD with at least 1 significant coronary artery stenosis, defined as diameter stenosis >50% and FFR ≤0.80 (or iFR/RFR ≤0.89)
- •Previous coronary artery bypass grafting (CABG)
- •Left ventricular systolic dysfunction, defined as ejection fraction (EF) <40%
- •Severe valvular heart disease
- •Pregnant or breastfeeding women
- •Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine)
- •Inability or unwillingness to provide a valid informed consent to the study procedure at the time of baseline evaluation
结局指标
主要结局
investigate the prevalence of INOCA in women vs. men
时间窗: 3 year
1\. To investigate the prevalence of INOCA in women vs. men who are referred for a clinically indicated coronary angiography in three Centers in North-ern, Central and Southern Italy;
stratify in INOCA endotypes patients
时间窗: 1 day (during physiology tests)
2\. to stratify in INOCA endotypes patients according to the presence or absence of alternative (i.e. non obstructive CAD) causes of myocardial ischemia detected during CA clinically indicated through physiology tests
implement a stratified therapy
时间窗: 1 year
3\. to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 1 year follow up
次要结局
未报告次要终点
研究者
Chieffo Alaide
Interventional cardiologist
IRCCS San Raffaele