Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

NCT ID: NCT04485234

Last Updated: 2021-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-03-25

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Microvascular Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

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

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

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Tergooi Hospital

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Tsuchiura Kyodo General Hospital

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Gifu Heart Center

OTHER

Sponsor Role collaborator

Toda Central General Hospital

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Tim van de Hoef

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cincinnati University Medical Center

Cincinnati, Ohio, United States

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Catholic University of the Sacred Heart

Roma, , Italy

Site Status

Gifu Heart Center

Gifu, , Japan

Site Status

Toda Central General Hospital

Toda, , Japan

Site Status

Tsuchiura Kyodo General Hospital

Tsuchiura, , Japan

Site Status

Amsterdam UMC - location AMC

Amsterdam, , Netherlands

Site Status

Tergooi

Blaricum, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Countries

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United States Denmark Italy Japan Netherlands South Korea Spain

References

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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.

Reference Type DERIVED
PMID: 38840578 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37558604 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36658168 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36372287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35876408 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35694826 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35589234 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35490124 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35475358 (View on PubMed)

Other Identifiers

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ILIAS Registry

Identifier Type: -

Identifier Source: org_study_id

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