Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

Coronary Artery Disease Clinical Trial

— ILIAS Registry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485234
• Other study ID #: ILIAS Registry
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2322
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Microvascular Coronary Artery Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance
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).

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Italy	Catholic University of the Sacred Heart	Roma
Japan	Gifu Heart Center	Gifu
Japan	Toda Central General Hospital	Toda
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Netherlands	Amsterdam UMC - location AMC	Amsterdam
Netherlands	Tergooi	Blaricum
Netherlands	Amphia Hospital	Breda
Spain	Hospital Clinico San Carlos	Madrid
United States	Cincinnati University Medical Center	Cincinnati	Ohio

Sponsors (16)

Lead Sponsor

Collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Aarhus University Hospital, Amphia Hospital, Catholic University of the Sacred Heart, Gifu Heart Center, Hospital San Carlos, Madrid, Inje University, Keimyung University Dongsan Medical Center, Samsung Medical Center, Seoul National University Hospital, Tergooi Hospital, Toda Central General Hospital, Tsuchiura Kyodo General Hospital, Ulsan University Hospital, University of Cincinnati, VU University Medical Center

Countries where clinical trial is conducted

United States,  Denmark,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization	10 years
Secondary	Target vessel failure	Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization	10 years
Secondary	Individual components of MACE and TVF	Cumulative incidence of the individual components of MACE and TVF	10 years