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

NCT05164640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Cardiac Ischemia

Interventions

OTHER

not required

This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms

Sponsors & Collaborators

  • Advice Pharma Group srl

    collaborator INDUSTRY

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Alaide Chieffo, MD · IRCCS San Raffaele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164640 on ClinicalTrials.gov