Abstract
BackgroundCerebrovascular 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. 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). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke.Methods/designThis 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. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. 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 primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months.DiscussionMeasurement 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. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016.All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.
Highlights
Stroke is the second most common cause of death and the major cause of disability worldwide after ischemic heart disease, especially in developing countries [1]
Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and its efficacy and evaluation accuracy need to be established in randomized controlled settings
The treatment of ischemic stroke has been investigated by a number of high-quality trials: The Japanese extracranialintracranial 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% and cerebrovascular reactivity (CVR) < 10% as a historical control, the incidence of ipsilateral stroke recurrence was significantly lower in the JET2 study, demonstrating that EC-IC bypass surgery is unlikely to benefit patients with CBF > 80% or Cerebrovascular reactivity (CVR) > 10% [3]
Summary
Previous studies have shown that medical management, PTAS, and IC-EC bypass can be applied to ischemicstroke patients; which treatment method is more beneficial has remained elusive [4, 15]. The present trial was designed to indicate whether measurement of CVR using multimodal imaging is helpful to improve the treatment strategy for adult patients with intracranial arterial stenosis or occlusion. Increased risk of stroke was found to be associated with hemodynamic failure, which can be assessed with measurement of CBF using (15O-)H2O PET [16]. This gold-standard technique, has not been presented for routine clinical imaging. CVR in the ischemic-stroke patients was evaluated by multimodal imagine methods because those are widely applicable to assess whole-brain quantitative CVR. Regarding the major challenges in performing a clinical trial on ischemic stroke, the necessity for huge amounts of data is inevitable.
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