Cardiac Ischemia
Conditions
Keywords
non-obstructive coronary artery disease
Brief summary
Prospective, interventional, multicentre, non-randomized, single-arm open-label study that aims to enroll 200 consecutive patients with suspected chronic ischemic heart disease in the absence of obstructive coronary artery disease (INOCA) at clinically indicated coronary angiography in 3 Italian centers. During coronary angiography, these patients will be simultaneously subjected to a functional and coronary physiology study (according to the methods reported below): * Functional evaluation with fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of angiographic stenosis\> 50%; * In the presence of coronary angiographic stenosis \<50% or\> 50% but in the presence of a negative functional assessment (FFR\> 0.80 and iFR / RFR\> 0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be measured. IMR and CFR will be assessed using intra-coronary guidance; * In the presence of CFR\> 2.0 and IMR \<25, tests with acetylcholine will also be performed in order to evaluate the possible presence of epicardial (focal or diffuse) or microvascular spasm.
Interventions
OTHERnot required
This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms
Sponsors
Advice Pharma Group srl
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical presentation of chronic ischemic heart disease (IHD), requiring coronary angiography for the diagnosis * Absence of obstructive 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 diameter stenosis \>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 informed consent to the study procedure at the time of baseline evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stratify in INOCA endotypes patients | 1 day (during physiology tests) | 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 |
| investigate the prevalence of INOCA in women vs. men | 3 year | 1\. To investigate the prevalence of INOCA in women vs. men who are referred for a clinically indicated coronary angiography in three Centers in North-ern, Central and Southern Italy; |
| implement a stratified therapy | 1 year | 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 1 year follow up |
Countries
Italy
Outcome results
None listed