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RECRUITINGOBSERVATIONAL

INOCA-NA a Local Prospective Registry

Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to the study procedure at the time of baseline evaluation; Who Should NOT Join This Trial: 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 \>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 in- formed consent to the study procedure at the time of baseline evaluation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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; 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 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; * 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.

Locations (1)

DPT of Advanced Biomedical Sciences
Naples, Italy, Italy