Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The present study has the following objectives:
- To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital;
- 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;
- 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 5 year follow up
详细描述
Eligible patients with angina and/or positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows:
- Functional evaluation by fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angio- graphically considered > 50%;
- In case of stenosis <50% or >50% but with negative functional evaluation (FFR >0.80 and iFR/RFR
>0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed. IMR and CFR will be evaluated, using an intracoro- nary wire;
- In case of CFR>2.0 and IMR<25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical presentation of chronic ischemic heart dis- ease (IHD), requiring coronary angiography for the diagnosis;
- •Absence of obstructive coronary artery disease (CAD) at coronary angiography;
- •Age &gt; 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 diameterstenosis &gt;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) &lt;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 in- formed consent to the study procedure at the time of baseline evaluation.
结局指标
主要结局
MACE
时间窗: 12 and 60 months
Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization
Degree of Angina
时间窗: 12 and 60 months
The degree of angina will be assessed using The Seattle Angina Questionnaire - 7 (SAQ-7) contains 7 questions used to measure health status in patients with coronary artery disease (CAD). The score is generated for each domain and it is scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
QoL
时间窗: 12 and 60 months
Quality of life will be assessed using the 5-level EuroQoL 5-dimensions Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN/DISCOMFORT and ANXIETY / DEPRESSION), but each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. An EQ-5D health state is deemed to be 'better' than another if it is better on at least one dimension and is no worse in any other dimension. An EQ-5D health state is deemed to be 'worse' than another if it is worse in at least one dimension and is no better in any other dimension.
次要结局
未报告次要终点
研究者
Luigi Di Serafino
Principal Investigator, Clinical Professor
Federico II University