Cardiac Ischemia Clinical Trial
— INOCAITOfficial title:
Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
Verified date | April 2024 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 29, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Hospital | Milan | |
Italy | Azienda Ospedaliera Universitaria Federico II, | Napoli | |
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS, | Roma |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele | Advice Pharma Group srl |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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) | |
Primary | 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 |
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