RecruitingNCT06588244

INOCA-NA a Local Prospective Registry

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


Sponsor

Federico II University

Enrollment

250 participants

Start Date

Sep 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Locations(1)

DPT of Advanced Biomedical Sciences

Naples, Italy, Italy

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NCT06588244


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