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

NCT05164640 | Completed DMC

• 1 other identifier: RF-2019-12369486
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Keywords

non-obstructive coronary artery disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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

Study Arms (1)

assessment of coronary physiology

OTHER

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 .

Other: not required

Interventions

not required OTHER

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

assessment of coronary physiology

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Advice Pharma Group srl: collaborator

Study Sites (3)

San Raffaele Hospital

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Federico II,

Napoli, 80131, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alaide Chieffo, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)