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Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04485234
Acronym
ILIAS Registry
Enrollment
2322
Registered
2020-07-24
Start date
2019-06-01
Completion date
2021-03-25
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Microvascular Coronary Artery Disease

Keywords

Coronary flow reserve, Fractional flow reserve, Microvascular resistance, Thermodilution, Doppler flow velocity

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.

Interventions

DIAGNOSTIC_TESTResting 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).

Sponsors

Amsterdam UMC, location VUmc
CollaboratorOTHER
Tergooi Hospital
CollaboratorOTHER
Amphia Hospital
CollaboratorOTHER
Seoul National University Hospital
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Inje University
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Tsuchiura Kyodo General Hospital
CollaboratorOTHER
Hospital San Carlos, Madrid
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Catholic University of the Sacred Heart
CollaboratorOTHER
University of Cincinnati
CollaboratorOTHER
Gifu Heart Center
CollaboratorOTHER
Toda Central General Hospital
CollaboratorUNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac events10 yearsCumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

Secondary

MeasureTime frameDescription
Target vessel failure10 yearsCumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Individual components of MACE and TVF10 yearsCumulative incidence of the individual components of MACE and TVF

Countries

Denmark, Italy, Japan, Netherlands, South Korea, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026