Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry

Study Overview
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Brief Summary
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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.

Official Title
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Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry

Conditions
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Cardiac Ischemia

Intervention / Treatment
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* Other: not required


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: assessment of coronary physiology<br>This is a prospective, multicentric, non-randomized , single-arm , open label clinical study. Included patients will be studied with invasive functional tests performed during index coronary angiography. These will include FFR, instantaneous Wave-Free Ratio (iFR), Resting Ful-Cycle Ra-tio (RFR), CFR, IMR and provocative Acetylcholine test. After the diagnosis of vasospastic angina (VSA) or coronary microvascular dysfunction (CMD) is made, a stratified medical therapy will then be initiated according to the results of physiological assessment according to ESC guidelines and recent EAPCI expert consensus document . | Other: not required<br>* This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate the prevalence of INOCA in women vs. men | 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; | 3 year | 
| stratify in INOCA endotypes patients | 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 | 1 day (during physiology tests) | 
| implement a stratified therapy | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-obstructive coronary artery disease