BMJ open · 2026
Causal discovery and treatment effect heterogeneity of futile recanalisation (CADISTH) for large vessel occlusion stroke: protocol and rationale for a multicentre prospective cohort study.
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Liu Zuting, Luo Tian, Yin Min, Wu Xiangbin, Liu Jingjing, Zhang Hongxiang, Le Huahui, Chen Weiping, Xia Zhongbin, Li Tianpei, Hu Chunlin, Huang Kun, Mo Jiali, Tu Jianglong, Kuang Jie
Аннотация
INTRODUCTION: Endovascular therapy (EVT) achieves high rates of successful recanalisation (modified Thrombolysis in Cerebral Infarction ≥2 b) in large vessel occlusion (LVO) stroke; however, functional recovery remains limited. Futile recanalisation (FR)—defined as poor functional outcome (modified Rankin Scale (mRS) 3–6) despite successful reperfusion—occurs in over half of patients. The underlying causal mechanisms and inter-individual heterogeneity of FR remain poorly understood, hindering effective prevention and personalised management. This study aims to apply causal discovery algorithms to identify determinants of FR and to quantify heterogeneous treatment effects using causal forest models.
METHODS AND ANALYSIS: Causal discovery and treatment effect heterogeneity (CADISTH) is a multicentre prospective cohort study. Consecutive acute ischaemic stroke patients with LVO who achieve successful reperfusion after EVT initiated within 24 hours of onset will be enrolled. The primary outcome is FR (mRS 3–6 at 90 days). Secondary outcomes include: (a) efficacy—neurological status (National Institutes of Health Stroke Scale (NIHSS)) and quality of life (EuroQol 5-Dimension 5-Level Version (EQ-5D-5L)) assessed at 24 hours, 7 days and 90, 180 and 365 days and (b) safety—symptomatic intracranial haemorrhage within 48 hours and all-cause mortality at 90, 180 and 365 days. The CADISTH study will: (1) explore candidate causal structures underlying FR by integrating real-world data with automated causal discovery algorithms and (2) characterise heterogeneity in treatment effects of modifiable factors across patient subgroups to inform prevention strategies and individualised patient selection.
ETHICS AND DISSEMINATION: The study protocol has been approved by the Biomedical Research Ethics Committee of the Second Affiliated Hospital of Nanchang University (No. [2025] 41) with local approval at each site. All participants will provide written informed consent prior to enrolment. Findings will be disseminated through peer-reviewed publication and conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2500103993.
METHODS AND ANALYSIS: Causal discovery and treatment effect heterogeneity (CADISTH) is a multicentre prospective cohort study. Consecutive acute ischaemic stroke patients with LVO who achieve successful reperfusion after EVT initiated within 24 hours of onset will be enrolled. The primary outcome is FR (mRS 3–6 at 90 days). Secondary outcomes include: (a) efficacy—neurological status (National Institutes of Health Stroke Scale (NIHSS)) and quality of life (EuroQol 5-Dimension 5-Level Version (EQ-5D-5L)) assessed at 24 hours, 7 days and 90, 180 and 365 days and (b) safety—symptomatic intracranial haemorrhage within 48 hours and all-cause mortality at 90, 180 and 365 days. The CADISTH study will: (1) explore candidate causal structures underlying FR by integrating real-world data with automated causal discovery algorithms and (2) characterise heterogeneity in treatment effects of modifiable factors across patient subgroups to inform prevention strategies and individualised patient selection.
ETHICS AND DISSEMINATION: The study protocol has been approved by the Biomedical Research Ethics Committee of the Second Affiliated Hospital of Nanchang University (No. [2025] 41) with local approval at each site. All participants will provide written informed consent prior to enrolment. Findings will be disseminated through peer-reviewed publication and conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2500103993.