Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

Completed

• Conditions: Coronary Artery Disease; Microvascular Coronary Artery Disease
• Interventions: Diagnostic Test: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance

• Registration Number: NCT04485234
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Status Verified: 2021-03
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance	All lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	10 years	Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Cincinnati University Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Catholic University of the Sacred Heart; 🇮🇹 Roma, Italy

Gifu Heart Center; 🇯🇵 Gifu, Japan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Amsterdam UMC - location AMC; 🇳🇱 Amsterdam, Netherlands

Toda Central General Hospital; 🇯🇵 Toda, Japan

Tsuchiura Kyodo General Hospital; 🇯🇵 Tsuchiura, Japan

Amphia Hospital; 🇳🇱 Breda, Netherlands

Tergooi; 🇳🇱 Blaricum, Netherlands

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of