Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemia, Myocardial
- Sponsor
- Federico II University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- MACE
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The present study has the following objectives:
- 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;
- 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;
- 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.
Investigators
Luigi Di Serafino
Principal Investigator, Clinical Professor
Federico II University
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 \&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 \&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) \&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.
Outcomes
Primary Outcomes
MACE
Time Frame: 12 and 60 months
Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization
Degree of Angina
Time Frame: 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
Time Frame: 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.