Clinical trial NCT06588244: INOCA-NA a Local Prospective Registry
Official title: Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemia, Myocardial
Non-Obstructive Coronary Atherosclerosis
Microcirculatory Status
Coronary Microvascular Dysfunction (CMD)
Keywords: INOCA
CMD
VSA
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with signs or symptoms potentially related to myocardial ischemia and requiring a functional coronary angiography for specific diagnosis will be enrolled.

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 \&gt; 50%;
* In case of stenosis \&lt;50% or \&gt;50% but with negative functional evaluation (FFR \&gt;0.80 and iFR/RFR

  \&gt;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\&gt;2.0 and IMR\&lt;25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.

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 \&amp;gt; 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 \&amp;gt;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) \&amp;lt;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 outcomes:
measure: MACE
timeFrame: 12 and 60 months
measure: Degree of Angina
timeFrame: 12 and 60 months
measure: QoL
timeFrame: 12 and 60 months
Secondary outcomes:
Other outcomes:
measure: TIMI Frame Count
timeFrame: up to 24 hours
measure: EndoPAT_Endoscore
timeFrame: 1 day and 12 months
measure: EndoPAT_RH
timeFrame: 1 day and 12 months
measure: Nitrates effects on CFR
timeFrame: up to 5 minutes
measure: Nitrates effects on MMR
timeFrame: up to 5 minutes
Locations:
city: Naples
country: Italy
facility: DPT of Advanced Biomedical Sciences
Study officials:
References: