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Clinical Trials in Italy / NCT06588244
Recruiting Observational

INOCA-NA a Local Prospective Registry

NCT06588244 · tracked via the Priya Life Science Italy tracker
Sponsor
Federico II University
Phase
Observational
Started
2024-09-19
Last updated
2025-03-17

Condition(s) studied

Ischemia, MyocardialNon-Obstructive Coronary AtherosclerosisMicrocirculatory StatusCoronary Microvascular Dysfunction (CMD)

Study 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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
DPT of Advanced Biomedical Sciences Naples Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588244 on ClinicalTrials.gov ↗ ← All trials in Italy