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

Last updated: April 8, 2024
Sponsor: IRCCS San Raffaele
Overall Status: Completed

Phase

N/A

Condition

Coronary Artery Disease

Hypercholesterolemia

Atherosclerosis

Treatment

not required

Clinical Study ID

NCT05164640
RF-2019-12369486
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical presentation of chronic ischemic heart disease (IHD), requiring coronaryangiography for the diagnosis
  • Absence of obstructive CAD at coronary angiography
  • Age > 18 years
  • Ability to provide a valid informed consent to the study procedure at the time ofbaseline evaluation

Exclusion

Exclusion Criteria:

  • Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock
  • Presence of obstructive CAD with at least 1 significant coronary artery stenosis,defined as diameter stenosis >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 coronaryphysiology testing (adenosine, nitrates, acetylcholine)
  • Inability or unwillingness to provide a valid informed consent to the study procedureat the time of baseline evaluation

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: not required
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • San Raffaele Hospital

    Milan, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II,

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS,

    Roma, 00168
    Italy

    Site Not Available

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