The present study has the following objectives:
1. 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; 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; 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 5 year follow up
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 > 18 years.
Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation;
Presence of obstructive CAD with at least 1 significant coronary artery stenosis, defined as diameterstenosis >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;
All patients presenting with signs or symptoms potentially related to myocardial ischemia and requiring a functional coronary angiography for specific diagnosis will be enrolled.
Cohort
Prospective
Not listed
MACE
Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization
Degree of Angina
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
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.
TIMI Frame Count
To evaluate the accuracy of TIMI Frame Count (TFC) to identify specific INOCA endotypes. TFC will be evaluated dunring invasive assessement before and after administration of nitrates. Patients with different INOCA endotypes will be compared in terms of TFC.
EndoPAT_Endoscore
To evaluate whether the assessment of peripheral microcirculation, as assessed with EndoPAT test might be useful to identify specific INOCA endotypes. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT). We will evaluate the Endoscore which has been previosly reported to be significantly decreased in patients with coronary artery disease, thereby the lower the endoscore the higher the risk of endothelial dysfunction.
EndoPAT_RH
To evaluate whether the assessment of peripheral microcirculation, as assessed with EndoPAT test might be useful to identify specific INOCA endotypes. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT). We will evaluate the Reactive Hyperemic Index (RHI) which has been found to be significantly decreased in patients with coronary artery disease, thereby the lower the RHI values the higher the risk of endothelial dysfunction.
Nitrates effects on CFR
To evaluate any changes in terms of hemodynamic parameters after i.c. administration of nitrates, which is normally administered during the invasive functional coronary angiography. In particular, we will evaluate the Coronary Flow Reserve (CFR), measured as the ratio between the mean transit time at rest and the mean transit time during maximal hyperemia.
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