Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

Study Overview
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Brief Summary
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This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.

Detailed Description
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ILIAS registry is a global effort to gather lesion-level data on the diagnostic and prognostic value of combined coronary pressure and flow measurements in clinical practice. Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA), using either coronary Doppler velocity measurements or coronary thermodilution measurements to obtain invasive coronary flow assessment. Patient treatment was governed by the local clinical practice guidelines at the time of the invasive procedure, but was at the operator's discretion. A standardized data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel evaluation was used.

Official Title
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Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)

Conditions
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Coronary Artery Disease, Microvascular Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: underwent combined measurements of coronary pressure and flow for at least 1native coronary artery Exclusion Criteria: hemodynamic instability culprit vessel of acute coronary syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>All lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution | Diagnostic Test: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance<br>* Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure | Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization | 10 years | 
| Individual components of MACE and TVF | Cumulative incidence of the individual components of MACE and TVF | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary flow reserve, Fractional flow reserve, Microvascular resistance, Thermodilution, Doppler flow velocity