INOCA-NA a Local Prospective Registry

NCT ID: NCT06588244

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2027-09-01

Brief Summary

The present study has the following objectives:

1. To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital;

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;

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 5 year follow up

Detailed Description

Eligible patients with angina and/or positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows:

• Functional evaluation by fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angio- graphically considered > 50%;
• In case of stenosis <50% or >50% but with negative functional evaluation (FFR >0.80 and iFR/RFR

>0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed. IMR and CFR will be evaluated, using an intracoro- nary wire;

• In case of CFR>2.0 and IMR<25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.

Conditions

Ischemia, Myocardial; Non-Obstructive Coronary Atherosclerosis; Microcirculatory Status; Coronary Microvascular Dysfunction (CMD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

INOCA

Patients presenting with symptoms or signs of myocardial ischemia with non-obstructing coronary artery disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Clinical presentation of chronic ischemic heart dis- ease (IHD), requiring coronary angiography for the diagnosis;
• Absence of obstructive coronary artery disease (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 diameterstenosis >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 in- formed consent to the study procedure at the time of baseline evaluation.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Luigi Di Serafino

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DPT of Advanced Biomedical Sciences

Naples, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luigi Di Serafino, MD, PhD

Role: CONTACT

luigi.diserafino@unina.it

0039 347917374

Facility Contacts

Stefano Cristiano

Role: primary

stefano.cristiano@unina.it

+300817463075

Other Identifiers

160/2024

Identifier Type: -

Identifier Source: org_study_id