INOCA-NA a Local Prospective Registry

Recruiting

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

• Registration Number: NCT06588244
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-09-04
• Study Start: 2024-09-19
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	12 and 60 months	Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization
Degree of Angina	12 and 60 months	The degree of angina will be assessed using The Seattle Angina Questionnaire - 7 (SAQ-7) contains 7 questions used to measure health status in patients with coronary artery disease (CAD). The score is generated for each domain and it is scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
QoL	12 and 60 months	Quality of life will be assessed using the 5-level EuroQoL 5-dimensions Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN/DISCOMFORT and ANXIETY / DEPRESSION), but each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. An EQ-5D health state is deemed to be 'better' than another if it is better on at least one dimension and is no worse in any other dimension. An EQ-5D health state is deemed to be 'worse' than another if it is worse in at least one dimension and is no better in any other dimension.

Trial Locations

Locations (1)

DPT of Advanced Biomedical Sciences; 🇮🇹 Naples, Italy