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Coronary Artery DiseaseILIAS RegistryNCT04485234

Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

An observational study of Coronary Artery Disease and Microvascular Coronary Artery Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance
How many people
2,322 participants
Where
12 sitesin 7 countries
Study dates
1 Jun 2019to 25 Mar 2021
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing clinically indicated invasive coronary angiography and with an indication for invasive physiological evaluation of at least 1 native coronary artery.

Who may be able to join

  • underwent combined measurements of coronary pressure and flow for at least 1native coronary artery

Who cannot join

  • hemodynamic instability
  • culprit vessel of acute coronary syndrome

Trial locations and contacts

12 sites in 7 countries.

12 sites in 7 countries

Japan3 sites
  • Gifu Heart Center

    Gifu

  • Toda Central General Hospital

    Toda

  • Tsuchiura Kyodo General Hospital

    Tsuchiura

Other trials in Japan

Netherlands3 sites
  • Amsterdam UMC - location AMC

    Amsterdam

  • Tergooi

    Blaricum

  • Amphia Hospital

    Breda

Other trials in Netherlands

South Korea2 sites
  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

United States1 site
  • Cincinnati University Medical Center

    Cincinnati, Ohio, 45219

Other trials in United States

Denmark1 site
  • Aarhus University Hospital

    Aarhus

Other trials in Denmark

Italy1 site
  • Catholic University of the Sacred Heart

    Roma

Other trials in Italy

Spain1 site
  • Hospital Clinico San Carlos

    Madrid

Other trials in Spain

About this study

Official title: Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS 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.

Read the 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.

Being tested
Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance
Keywords
Coronary flow reserve, Fractional flow reserve, Microvascular resistance, Thermodilution, Doppler flow velocity
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistanceDiagnostic 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).

Study groups in NCT04485234
Study groupRoleWhat they receive
All patientsAll lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution
Receives: Diagnostic Test: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac events

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

    Measured: 10 years

Secondary outcomes (2)
  1. Target vessel failure

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

    Measured: 10 years

  2. Individual components of MACE and TVF

    Cumulative incidence of the individual components of MACE and TVF

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start1 Jun 2019
  3. Primary completion25 Mar 2021
  4. Study completion25 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,322 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485234
Sponsor's protocol ID
ILIAS Registry
Acronym
ILIAS Registry
Status last verified
Mar 2021
First submitted
21 Jul 2020
Last updated
29 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized patient level data will be made available by the corresponding author for reasonable requests. Consent was not obtained for data sharing but the presented data are fully anonymized and risk of identification is negligible.

Publications

  • Manegaonkar SM, Effat MA, van de Hoef TP, Lee JM, Boerhout CKM, Lee SH, de Waard GA, Jung JH, Renteria HM, Hoshino M, Pinto ME, Meuwissen M, Matsuo H, Cambero MM, Eftekhari A, Murai T, Marques K, Doh JH, Christiansen EH, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Chamuleau SAJ, van Royen N, Knaapen P, Kakuta T, Escaned J, Piek JJ, Koo BK, Banerjee RK. Delineating coronary epicardial stenosis status from microvascular dysfunction using pressure-drop coefficient from multicenter ILIAS registry. Int J Cardiol. 2026 Jan 1;442:133864. doi: 10.1016/j.ijcard.2025.133864. Epub 2025 Sep 6.

    PubMed 40921272
  • Boerhout CKM, Echavarria-Pinto M, de Waard GA, Lee JM, Mejia-Renteria H, Hun Lee S, Jung JH, Hoshino M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Beijk MAM, van Royen N, Knaapen P, Escaned J, Kakuta T, Koo BK, Piek JJ, van de Hoef TP, Meuwissen M. Impact of hyperaemic stenosis resistance on long-term outcomes of stable angina in the ILIAS Registry. EuroIntervention. 2024 Jun 3;20(11):e699-e706. doi: 10.4244/EIJ-D-23-00713.

    PubMed 38840578
  • Boerhout CKM, Vink CEM, Lee JM, de Waard GA, Mejia-Renteria H, Lee SH, Jung JH, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Appelman Y, Beijk MAM, van Royen N, Chamuleau SAJ, Knaapen P, Escaned J, Kakuta T, Koo BK, Piek JJ, van de Hoef TP. Impact of sex on the assessment of the microvascular resistance reserve. Int J Cardiol. 2024 May 1;402:131832. doi: 10.1016/j.ijcard.2024.131832. Epub 2024 Feb 3.

    PubMed 38316189
  • Vink CEM, Woudstra J, Lee JM, Boerhout CKM, Cook CM, Hoshino M, Mejia-Renteria H, Lee SH, Jung JH, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Beijk MAM, Doh JH, Piek JJ, van de Hoef TP, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, van Royen N, Chamuleau SAJ, Knaapen P, Escaned J, Kakuta T, Koo BK, Appelman Y, de Waard GA. Sex differences in prevalence and outcomes of the different endotypes of chronic coronary syndrome in symptomatic patients undergoing invasive coronary angiography: Insights from the global ILIAS invasive coronary physiology registry. Atherosclerosis. 2023 Nov;384:117167. doi: 10.1016/j.atherosclerosis.2023.06.073. Epub 2023 Jul 8.

    PubMed 37558604
  • Hoshino M, van de Hoef TP, Lee JM, Hamaya R, Kanaji Y, Boerhout CKM, de Waard GA, Jung JH, Lee SH, Mejia-Renteria H, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Marques K, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Murai T, Nakayama M, Tanaka N, Shin ES, Sasano T, Appelman Y, Beijk M, Knaapen P, van Royen N, Escaned J, Koo BK, Piek JJ, Kakuta T. Abnormal physiological findings after FFR-based revascularisation deferral are associated with worse prognosis in women. Sci Rep. 2023 Jan 19;13(1):1027. doi: 10.1038/s41598-023-28146-6.

    PubMed 36658168
  • Boerhout CKM, de Waard GA, Lee JM, Mejia-Renteria H, Lee SH, Jung JH, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Chamuleau SAJ, van Royen N, Knaapen P, Escaned J, Kakuta T, Koo BK, Piek JJ, van de Hoef TP. Combined use of hyperemic and non-hyperemic pressure ratios for revascularization decision-making: From the ILIAS registry. Int J Cardiol. 2023 Jan 1;370:105-111. doi: 10.1016/j.ijcard.2022.11.015. Epub 2022 Nov 11.

    PubMed 36372287
  • Joh HS, Shin D, Lee JM, Lee SH, Hong D, Choi KH, Hwang D, Boerhout CKM, de Waard GA, Jung JH, Mejia-Renteria H, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Kim HK, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Chamuleau SAJ, van Royen N, Knaapen P, Koo BK, Kakuta T, Escaned J, Piek JJ, van de Hoef TP; ILIAS Registry Investigators [Link]. Prognostic Impact of Coronary Flow Reserve in Patients With Reduced Left Ventricular Ejection Fraction. J Am Heart Assoc. 2022 Aug 2;11(15):e025841. doi: 10.1161/JAHA.122.025841. Epub 2022 Jul 25.

    PubMed 35876408
  • Boerhout CKM, de Waard GA, Lee JM, Mejia-Renteria H, Lee SH, Jung JH, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Appelman Y, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Beijk MAM, Knaapen P, Escaned J, Kakuta T, Koo BK, Piek JJ, van de Hoef TP. Prognostic value of structural and functional coronary microvascular dysfunction in patients with non-obstructive coronary artery disease; from the multicentre international ILIAS registry. EuroIntervention. 2022 Oct 21;18(9):719-728. doi: 10.4244/EIJ-D-22-00043.

    PubMed 35694826
  • van de Hoef TP, Lee JM, Boerhout CKM, de Waard GA, Jung JH, Lee SH, Mejia-Renteria H, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, van Royen N, Chamuleau SAJ, Knaapen P, Escaned J, Kakuta T, Koo BK, Piek JJ. Combined Assessment of FFR and CFR for Decision Making in Coronary Revascularization: From the Multicenter International ILIAS Registry. JACC Cardiovasc Interv. 2022 May 23;15(10):1047-1056. doi: 10.1016/j.jcin.2022.03.016.

    PubMed 35589234
  • Kim J, Shin D, Lee JM, Lee SH, Hong D, Choi KH, Hwang D, Boerhout CKM, de Waard GA, Jung JH, Mejia-Renteria H, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Kim HK, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Chamuleau SAJ, van Royen N, Knaapen P, Koo BK, Kakuta T, Escaned J, Piek JJ, van de Hoef TP; ILIAS Registry Investigators. Differential Prognostic Value of Revascularization for Coronary Stenosis With Intermediate FFR by Coronary Flow Reserve. JACC Cardiovasc Interv. 2022 May 23;15(10):1033-1043. doi: 10.1016/j.jcin.2022.01.297. Epub 2022 Apr 27.

    PubMed 35490124
  • Lee SH, Shin D, Lee JM, van de Hoef TP, Hong D, Choi KH, Hwang D, Boerhout CKM, de Waard GA, Jung JH, Mejia-Renteria H, Hoshino M, Echavarria-Pinto M, Meuwissen M, Matsuo H, Madera-Cambero M, Eftekhari A, Effat MA, Murai T, Marques K, Doh JH, Christiansen EH, Banerjee R, Kim HK, Nam CW, Niccoli G, Nakayama M, Tanaka N, Shin ES, Chamuleau SAJ, van Royen N, Knaapen P, Koo BK, Kakuta T, Escaned J, Piek JJ; ILIAS Registry Investigators dagger. Clinical Relevance of Ischemia with Nonobstructive Coronary Arteries According to Coronary Microvascular Dysfunction. J Am Heart Assoc. 2022 May 3;11(9):e025171. doi: 10.1161/JAHA.121.025171. Epub 2022 Apr 27.

    PubMed 35475358

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Microvascular Coronary Artery Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 12 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan, Netherlands, South Korea, United States, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac events (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04485234, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.

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