INOCA-NA a Local Prospective Registry

Recruiting now

Conditions studied: Ischemia, Myocardial, Non-Obstructive Coronary Atherosclerosis, Microcirculatory Status, Coronary Microvascular Dysfunction (CMD)

In brief

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

Key facts

Study ID: NCT06588244
Run by: Federico II University
People needed: 250
Starts: 2024-09-19
Expected to finish: 2027-09-01
Last updated by the study team: 2025-03-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 \&gt; 18 years.
Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation;

You may not qualify if…

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 \&gt;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) \&lt;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.

Where it is running

DPT of Advanced Biomedical Sciences — Naples, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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