Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing

Coen K M Boerhout; Hanae F Namba; Tommy Liu; Marcel A M Beijk; Peter Damman; Martijn Meuwissen; Peter Ong; Udo Sechtem; Yolande Appelman; Colin Berry; Javier Escaned; Amir Lerman; Timothy D Henry; Pim van der Harst; Ronak Delewi; Jan J Piek; Tim P van de Hoef

doi:10.1016/j.ahj.2025.03.004

Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing

Coen K M Boerhout
, Hanae F Namba
, Tommy Liu
, Marcel A M Beijk
, Peter Damman
, Martijn Meuwissen
, Peter Ong
, Udo Sechtem
, Yolande Appelman
, Colin Berry
, Javier Escaned
, Amir Lerman
, Timothy D Henry
, Pim van der Harst
, Ronak Delewi
, Jan J Piek
, Tim P van de Hoef^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Angina with nonobstructive coronary arteries (ANOCA) is a major cause of chronic coronary syndromes, affecting nearly half of patients with anginal symptoms who undergo invasive coronary angiography. ANOCA may lead to substantial symptom burden, increased risk of adverse cardiac events, increased healthcare utilization due to ongoing symptoms, repeat hospitalizations, and invasive testing. The pathophysiology of ANOCA often involves a variety of coronary disorders, such as coronary microvascular dysfunction, epicardial or microvascular vasospasm and endothelial dysfunction. While coronary function testing (CFT) can identify each of these specific endotypes, in current practice it is used as a second- or third-line diagnostic tool, delaying diagnosis which contributes to persistent symptoms and diminished quality of life. The ILIAS ANOCA clinical trial aims to enhance understanding and management of ANOCA through early routine CFT-guided management.

METHODS: After exclusion of obstructive coronary artery disease, eligible patients undergo comprehensive CFT, and will be randomized to blinding of the CFT results (control group) or disclosure of the CFT results combined with a tailored medical therapy escalation plan (intervention group). The control group will be unblinded after 1 year. The primary outcome is the mean difference in the within-subject change in Seattle Angina Questionnaire (SAQ) summary score between the groups at 6 months from baseline. Secondary outcomes include differences in SAQ-summary score and additional health-status and quality of life questionnaires at 12 and 24 months from baseline.

CLINICAL TRIAL REGISTRATION: International Clinical Trials Registry Platform identifier NL-OMON20739.

Original language	English
Pages (from-to)	1-13
Number of pages	13
Journal	American Heart Journal
Volume	286
Early online date	9 Mar 2025
DOIs	https://doi.org/10.1016/j.ahj.2025.03.004
Publication status	Published - Aug 2025

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Boerhout, C. K. M., Namba, H. F., Liu, T., Beijk, M. A. M., Damman, P., Meuwissen, M., Ong, P., Sechtem, U., Appelman, Y., Berry, C., Escaned, J., Lerman, A., Henry, T. D., van der Harst, P., Delewi, R., Piek, J. J., & van de Hoef, T. P. (2025). Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing. American Heart Journal, 286, 1-13. https://doi.org/10.1016/j.ahj.2025.03.004

@article{c6309e2e26af453cb51d2fb3dbe1c7f5,

title = "Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing",

abstract = "BACKGROUND: Angina with nonobstructive coronary arteries (ANOCA) is a major cause of chronic coronary syndromes, affecting nearly half of patients with anginal symptoms who undergo invasive coronary angiography. ANOCA may lead to substantial symptom burden, increased risk of adverse cardiac events, increased healthcare utilization due to ongoing symptoms, repeat hospitalizations, and invasive testing. The pathophysiology of ANOCA often involves a variety of coronary disorders, such as coronary microvascular dysfunction, epicardial or microvascular vasospasm and endothelial dysfunction. While coronary function testing (CFT) can identify each of these specific endotypes, in current practice it is used as a second- or third-line diagnostic tool, delaying diagnosis which contributes to persistent symptoms and diminished quality of life. The ILIAS ANOCA clinical trial aims to enhance understanding and management of ANOCA through early routine CFT-guided management.METHODS: After exclusion of obstructive coronary artery disease, eligible patients undergo comprehensive CFT, and will be randomized to blinding of the CFT results (control group) or disclosure of the CFT results combined with a tailored medical therapy escalation plan (intervention group). The control group will be unblinded after 1 year. The primary outcome is the mean difference in the within-subject change in Seattle Angina Questionnaire (SAQ) summary score between the groups at 6 months from baseline. Secondary outcomes include differences in SAQ-summary score and additional health-status and quality of life questionnaires at 12 and 24 months from baseline.CLINICAL TRIAL REGISTRATION: International Clinical Trials Registry Platform identifier NL-OMON20739.",

author = "Boerhout, \{Coen K M\} and Namba, \{Hanae F\} and Tommy Liu and Beijk, \{Marcel A M\} and Peter Damman and Martijn Meuwissen and Peter Ong and Udo Sechtem and Yolande Appelman and Colin Berry and Javier Escaned and Amir Lerman and Henry, \{Timothy D\} and \{van der Harst\}, Pim and Ronak Delewi and Piek, \{Jan J\} and \{van de Hoef\}, \{Tim P\}",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s)",

year = "2025",

month = aug,

doi = "10.1016/j.ahj.2025.03.004",

language = "English",

volume = "286",

pages = "1--13",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Elsevier",

}

Boerhout, CKM, Namba, HF, Liu, T, Beijk, MAM, Damman, P, Meuwissen, M, Ong, P, Sechtem, U, Appelman, Y, Berry, C, Escaned, J, Lerman, A, Henry, TD, van der Harst, P, Delewi, R, Piek, JJ & van de Hoef, TP 2025, 'Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing', American Heart Journal, vol. 286, pp. 1-13. https://doi.org/10.1016/j.ahj.2025.03.004

TY - JOUR

T1 - Rationale and design of the ILIAS ANOCA clinical trial

T2 - A blinded-arm controlled trial for routine ad-hoc coronary function testing

AU - Boerhout, Coen K M

AU - Namba, Hanae F

AU - Liu, Tommy

AU - Beijk, Marcel A M

AU - Damman, Peter

AU - Meuwissen, Martijn

AU - Ong, Peter

AU - Sechtem, Udo

AU - Appelman, Yolande

AU - Berry, Colin

AU - Escaned, Javier

AU - Lerman, Amir

AU - Henry, Timothy D

AU - van der Harst, Pim

AU - Delewi, Ronak

AU - Piek, Jan J

AU - van de Hoef, Tim P

PY - 2025/8

Y1 - 2025/8

N2 - BACKGROUND: Angina with nonobstructive coronary arteries (ANOCA) is a major cause of chronic coronary syndromes, affecting nearly half of patients with anginal symptoms who undergo invasive coronary angiography. ANOCA may lead to substantial symptom burden, increased risk of adverse cardiac events, increased healthcare utilization due to ongoing symptoms, repeat hospitalizations, and invasive testing. The pathophysiology of ANOCA often involves a variety of coronary disorders, such as coronary microvascular dysfunction, epicardial or microvascular vasospasm and endothelial dysfunction. While coronary function testing (CFT) can identify each of these specific endotypes, in current practice it is used as a second- or third-line diagnostic tool, delaying diagnosis which contributes to persistent symptoms and diminished quality of life. The ILIAS ANOCA clinical trial aims to enhance understanding and management of ANOCA through early routine CFT-guided management.METHODS: After exclusion of obstructive coronary artery disease, eligible patients undergo comprehensive CFT, and will be randomized to blinding of the CFT results (control group) or disclosure of the CFT results combined with a tailored medical therapy escalation plan (intervention group). The control group will be unblinded after 1 year. The primary outcome is the mean difference in the within-subject change in Seattle Angina Questionnaire (SAQ) summary score between the groups at 6 months from baseline. Secondary outcomes include differences in SAQ-summary score and additional health-status and quality of life questionnaires at 12 and 24 months from baseline.CLINICAL TRIAL REGISTRATION: International Clinical Trials Registry Platform identifier NL-OMON20739.

AB - BACKGROUND: Angina with nonobstructive coronary arteries (ANOCA) is a major cause of chronic coronary syndromes, affecting nearly half of patients with anginal symptoms who undergo invasive coronary angiography. ANOCA may lead to substantial symptom burden, increased risk of adverse cardiac events, increased healthcare utilization due to ongoing symptoms, repeat hospitalizations, and invasive testing. The pathophysiology of ANOCA often involves a variety of coronary disorders, such as coronary microvascular dysfunction, epicardial or microvascular vasospasm and endothelial dysfunction. While coronary function testing (CFT) can identify each of these specific endotypes, in current practice it is used as a second- or third-line diagnostic tool, delaying diagnosis which contributes to persistent symptoms and diminished quality of life. The ILIAS ANOCA clinical trial aims to enhance understanding and management of ANOCA through early routine CFT-guided management.METHODS: After exclusion of obstructive coronary artery disease, eligible patients undergo comprehensive CFT, and will be randomized to blinding of the CFT results (control group) or disclosure of the CFT results combined with a tailored medical therapy escalation plan (intervention group). The control group will be unblinded after 1 year. The primary outcome is the mean difference in the within-subject change in Seattle Angina Questionnaire (SAQ) summary score between the groups at 6 months from baseline. Secondary outcomes include differences in SAQ-summary score and additional health-status and quality of life questionnaires at 12 and 24 months from baseline.CLINICAL TRIAL REGISTRATION: International Clinical Trials Registry Platform identifier NL-OMON20739.

U2 - 10.1016/j.ahj.2025.03.004

DO - 10.1016/j.ahj.2025.03.004

M3 - Article

C2 - 40068714

SN - 0002-8703

VL - 286

SP - 1

EP - 13

JO - American Heart Journal

JF - American Heart Journal

ER -

Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing

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