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

NCT ID: NCT05164640

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-02-29

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.

Conditions

Cardiac Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

assessment of coronary physiology

This is a prospective, multicentric, non-randomized , single-arm , open label clinical study.

Included patients will be studied with invasive functional tests performed during index coronary angiography. These will include FFR, instantaneous Wave-Free Ratio (iFR), Resting Ful-Cycle Ra-tio (RFR), CFR, IMR and provocative Acetylcholine test.

After the diagnosis of vasospastic angina (VSA) or coronary microvascular dysfunction (CMD) is made, a stratified medical therapy will then be initiated according to the results of physiological assessment according to ESC guidelines and recent EAPCI expert consensus document .

Group Type: OTHER

not required

Intervention Type: OTHER

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

Interventions

not required

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advice Pharma Group srl

INDUSTRY

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Chieffo Alaide

Interventional cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaide Chieffo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

San Raffaele Hospital

Milan, , Italy

Azienda Ospedaliera Universitaria Federico II,

Napoli, , Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, , Italy

Countries

Italy

Other Identifiers

RF-2019-12369486

Identifier Type: -

Identifier Source: org_study_id