NCT04485234

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

July 21, 2020

Last Update Submit

March 25, 2021

Conditions

Coronary Artery DiseaseMicrovascular Coronary Artery Disease

Keywords

Coronary flow reserveFractional flow reserveMicrovascular resistanceThermodilutionDoppler flow velocity

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

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

    10 years

Secondary Outcomes (2)

  • Target vessel failure

    10 years

  • Individual components of MACE and TVF

    10 years

Study Arms (1)

All patients

All lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution

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

Interventions

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).

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • hemodynamic instability
  • culprit vessel of acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cincinnati University Medical Center

Cincinnati, Ohio, 45219, United States

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Catholic University of the Sacred Heart

Roma, Italy

Location

Gifu Heart Center

Gifu, Japan

Location

Toda Central General Hospital

Toda, Japan

Location

Tsuchiura Kyodo General Hospital

Tsuchiura, Japan

Location

Amsterdam UMC - location AMC

Amsterdam, Netherlands

Location

Tergooi

Blaricum, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Related Publications (9)

  • 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.

    PMID: 38840578DERIVED

  • 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.

    PMID: 37558604DERIVED

  • 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.

    PMID: 36658168DERIVED

  • 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.

    PMID: 36372287DERIVED

  • 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.

    PMID: 35876408DERIVED

  • 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.

    PMID: 35694826DERIVED

  • 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.

    PMID: 35589234DERIVED

  • 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.

    PMID: 35490124DERIVED

  • 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.

    PMID: 35475358DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

June 1, 2019

Primary Completion

March 25, 2021

Study Completion

March 25, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

KR(2)JP(3)ES(1)IT(1)US(1)NL(3)DK(1)