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

IRCCS San Raffaele200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Cardiac Ischemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

San Raffaele Hospital

Milan, Italy

Azienda Ospedaliera Universitaria Federico II,

Napoli, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, Italy

Outcomes

Primary Outcomes

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;

Time frame: 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

Time frame: 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

Time frame: 1 year