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INOCA-NA a Local Prospective Registry

INOCA-NA a Local Prospective Registry

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Phase N/A

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Overview

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

Description

Eligible patients with angina and/or positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows:

  • Functional evaluation by fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angiographically considered > 50%;
  • In case of stenosis <50% or >50% but with negative functional evaluation (FFR >0.80 and iFR/RFR

>0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed. IMR and CFR will be evaluated, using an intracoro- nary wire;

  • In case of CFR>2.0 and IMR<25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (focal or diffuse) or microvascular spasm.

Eligibility

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.

Study details
    Ischemia
    Myocardial
    Non-Obstructive Coronary Atherosclerosis
    Microcirculatory Status
    Coronary Microvascular Dysfunction (CMD)

NCT06588244

Federico II University

15 October 2025

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