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Completed

NCT Number: NCT04485234

Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance

Diagnostic Test

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).

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 10 years

    Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

Secondary outcomes

  1. Target vessel failure

    Time frame: 10 years

    Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization

  2. Individual components of MACE and TVF

    Time frame: 10 years

    Cumulative incidence of the individual components of MACE and TVF

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Aarhus University Hospital
  • Amphia Hospital
  • Amsterdam UMC, location VUmc
  • 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

Registry information

Official study title

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

Acronym: ILIAS Registry

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Mar 29, 2021

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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