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Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry" — INOCAIT  

Cardiac Ischemia Clinical Trial

Official title:
Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"

Clinical Trial Summary

Prospective, interventional, multicentre, non-randomized, single-arm open-label study that aims to enroll 200 consecutive patients with suspected chronic ischemic heart disease in the absence of obstructive coronary artery disease (INOCA) at clinically indicated coronary angiography in 3 Italian centers. During coronary angiography, these patients will be simultaneously subjected to a functional and coronary physiology study (according to the methods reported below): - Functional evaluation with fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of angiographic stenosis> 50%; - In the presence of coronary angiographic stenosis <50% or> 50% but in the presence of a negative functional assessment (FFR> 0.80 and iFR / RFR> 0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be measured. IMR and CFR will be assessed using intra-coronary guidance; - In the presence of CFR> 2.0 and IMR <25, tests with acetylcholine will also be performed in order to evaluate the possible presence of epicardial (focal or diffuse) or microvascular spasm.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05164640
Study type Interventional
Source IRCCS San Raffaele
Contact
Status Completed
Phase N/A
Start date December 1, 2021
Completion date February 29, 2024
View Details
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