Status:
RECRUITING
INOCA-NA a Local Prospective Registry
Lead Sponsor:
Federico II University
Conditions:
Ischemia, Myocardial
Non-Obstructive Coronary Atherosclerosis
Eligibility:
All Genders
Brief 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 - Feder...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06588244
Start Date
September 19 2024
End Date
September 1 2027
Last Update
March 17 2025
Active Locations (1)
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1
DPT of Advanced Biomedical Sciences
Naples, Italy, Italy, 80131