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.
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
- Conditions the study is for
- Coronary Artery Disease, Microvascular Coronary Artery Disease
- 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
Netherlands3 sites
Amsterdam UMC - location AMC
Amsterdam
Tergooi
Blaricum
Amphia Hospital
Breda
South Korea2 sites
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
United States1 site
Cincinnati University Medical Center
Cincinnati, Ohio, 45219
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 group | Role | What they receive |
|---|---|---|
| All patients | All 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.
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)
Target vessel failure
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Measured: 10 years
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.
- First posted24 Jul 2020
- Study start1 Jun 2019
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Tergooi Hospital, Amphia Hospital, Seoul National University Hospital, Samsung Medical Center, Inje University, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Tsuchiura Kyodo General Hospital, Hospital San Carlos, Madrid, Aarhus University Hospital, Catholic University of the Sacred Heart, University of Cincinnati, Gifu Heart Center, Toda Central General Hospital
- Responsible party
- Principal investigator, Tim van de Hoef, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 40921272Boerhout 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 38840578Boerhout 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 38316189Vink 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 37558604Hoshino 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 36658168Boerhout 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 36372287Joh 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 35876408Boerhout 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 35694826van 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 35589234Kim 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 35490124Lee 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)
- ClinicalTrials.gov ID
- NCT04485234
- Acronym / sponsor ID
- ILIAS Registry / ILIAS Registry
- Keywords
- Coronary flow reserve, Fractional flow reserve, Microvascular resistance, Thermodilution, Doppler flow velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,322 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Tergooi Hospital, Amphia Hospital, Seoul National University Hospital, Samsung Medical Center, Inje University, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Tsuchiura Kyodo General Hospital, Hospital San Carlos, Madrid, Aarhus University Hospital, Catholic University of the Sacred Heart, University of Cincinnati, Gifu Heart Center, Toda Central General Hospital
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Diagnostic Test: Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistanceAll lesions undergo assessment with coronary pressure sensor and either Doppler velocity or coronary thermodilution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- underwent combined measurements of coronary pressure and flow for at least 1native coronary artery
Key exclusion criteria (2 listed)
- hemodynamic instability
- culprit vessel of acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistanceCalculation 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). | Diagnostic test | All patients |
Primary outcome
Major adverse cardiac events
Time frame: 10 years
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
2 secondary outcomes
Target vessel failure
Time frame: 10 years
Individual components of MACE and TVF
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 40921272Manegaonkar 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.
- Derived from this study: PubMed 38840578Boerhout 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.
- Derived from this study: PubMed 38316189Boerhout 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.
- Derived from this study: PubMed 37558604Vink 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.
- Derived from this study: PubMed 36658168Hoshino 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.
- Derived from this study: PubMed 36372287Boerhout 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.
- Derived from this study: PubMed 35876408Joh 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.
- Derived from this study: PubMed 35694826Boerhout 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.
- Derived from this study: PubMed 35589234van 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.
- Derived from this study: PubMed 35490124Kim 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.
- Derived from this study: PubMed 35475358Lee 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 7 countries: see every site and its status.
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.