However, the treatment strategy of intracranial arterial stenosis or occlusion mainly depends on the degree of vascular stenosis, with or without consideration of hemodynamic factors at the distal end-to-side anastomosis of a bypass graft and CVR factors, or steady-state vascular parameters, such as CBF and cerebral blood volume (CBV). AL Hasan conducted a trial for treating ischemic stroke, and showed a 14.7% risk of stroke or death in the stenting group versus 5.8% in the medical group at 30 days, and 23% in the stenting group versus 15% in the medical group at a median follow-up of 32.4 months. Another recent trial involving aggressive medical treatment with or without stenting in high-risk patients with intracranial arterial stenosis (SAMMPRIS), demonstrated the use of aggressive medical management rather than percutaneous transluminal angioplasty and stenting (PTAS) with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. The treatment of ischemic stroke has been investigated by a number of high-quality trials: The Japanese extracranial-intracranial bypass (EC-IC) bypass trial (JET2) study revealed that compared with the medical arm of the Japanese EC-IC bypass trial (JET) study including patients with cerebral blood flow (CBF) 80% or CVR > 10%. Therefore, an effective therapeutic approach for intracranial arterial stenosis is urgently required. A remarkable risk of recurrent ischemic stroke was reported in patients with symptomatic, major cerebral arterial occlusion or stenosis. Ischemic stroke occurs when a blood vessel supplying blood to a part of the brain is obstructed, and it accounts for about 87% of all strokes. Stroke is the second most common cause of death and the major cause of disability worldwide after ischemic heart disease, especially in developing countries. Trial registrationĬhinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635 Registered on 16 October 2016.Īll items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke. Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke.
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