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

Cardiac Ischemia Clinical Trial

— INOCAIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164640
• Other study ID #: RF-2019-12369486
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Ischemia
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan
Italy	Azienda Ospedaliera Universitaria Federico II,	Napoli
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS,	Roma

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Advice Pharma Group srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate the prevalence of INOCA in women vs. men	1. To investigate the prevalence of INOCA in women vs. men who are referred for a clinically indicated coronary angiography in three Centers in North-ern, Central and Southern Italy;	3 year
Primary	stratify in INOCA endotypes patients	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	1 day (during physiology tests)
Primary	implement a stratified therapy	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 1 year follow up	1 year