Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"

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.

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Key information

Conditions

Cardiac Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital, Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

not required

Other

This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms

Primary outcomes

investigate the prevalence of INOCA in women vs. men

Time frame: 3 year
- 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;
stratify in INOCA endotypes patients

Time frame: 1 day (during physiology tests)
- 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
implement a stratified therapy

Time frame: 1 year
- 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Advice Pharma Group srl

Registry information

Acronym: INOCAIT

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Dec 21, 2021
Registry last updated: Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed