Clinical trial NCT05164640: Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
Official title: Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Ischemia
Keywords: non-obstructive coronary artery disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Advice Pharma Group srl
First posted: 2021-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 Criteria:

* Clinical presentation of chronic ischemic heart disease (IHD), requiring coronary angiography 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 of baseline evaluation

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 coronary physiology testing (adenosine, nitrates, acetylcholine)
* Inability or unwillingness to provide a valid informed consent to the study procedure at the time of baseline evaluation

Primary outcomes:
measure: investigate the prevalence of INOCA in women vs. men
timeFrame: 3 year
measure: stratify in INOCA endotypes patients
timeFrame: 1 day (during physiology tests)
measure: implement a stratified therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II,
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS,
Study officials:
affiliation: IRCCS San Raffaele
name: Alaide Chieffo, MD
role: PRINCIPAL_INVESTIGATOR
References: