Trials / Recruiting

RecruitingNCT06588244

INOCA-NA a Local Prospective Registry

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 250 (estimated)

Sponsor: Federico II University · Academic / Other
Sex: All
Age: —
Healthy volunteers: Not accepted

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

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 (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angio- graphically 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 (fo- cal or diffuse) or microvascular spasm.

Conditions

Timeline

Start date: 2024-09-19
Primary completion: 2026-09-01
Completion: 2027-09-01
First posted: 2024-09-19
Last updated: 2025-03-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06588244. Inclusion in this directory is not an endorsement.