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

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-03-09 DOI:10.1016/j.ahj.2025.03.004

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

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引用次数: 0

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.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.