NCT05798013尚未招募不适用
Effectiveness of Digital Health Management on Patients With Head and Neck Vascular Stenosis: A Multicenter, Cluster Randomized Controlled Trial Based on Chinese Population
Yi Yang1 个研究点 分布在 1 个国家目标入组 102,072 人开始时间: 2025年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102,072
- 试验地点
- 1
- 主要终点
- New-onset stroke events at 24 months
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of digital health management for intervention on Chinese population with head and neck vascular stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria of the clusters
- •Hospitals with the qualification of "head and neck ultrasound center" in China.
- •Inclusion criteria for individuals
- •(1)Age ≥ 35 years old, with no restriction on gender.
- •(2)Patients with clinically diagnosed head and neck stenosis or occlusion, including mild, moderate or severe stenosis or occlusion of the carotid artery and mild, moderate or severe stenosis or occlusion of the intracranial artery.
- •(3)Ability to use a smartphone and have a mobile application installed on the handset.
- •(4)Subjects or their legal representatives agreed to the study and signed the project informed consent form.
排除标准
- •Exclusion criteria for the clusters
- •The included centers did not have the capacity to undertake the trial.
- •Exclusion criteria for individuals
- •(1)Combination of severe systemic diseases such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation dysfunction, malignancy, etc.
- •(2)Patients with a life expectancy of less than 2 years or who are unable to complete the study for other reasons.
结局指标
主要结局
New-onset stroke events at 24 months
时间窗: 24 months
New-onset stroke events include ischemic stroke, transient ischemic attack, and hemorrhagic stroke.
次要结局
- Composite and separate indicators of new clinical vascular events at 12 and 24 months(12 months, 24 months)
- New-onset stroke events at 12 months(12 months)
- All-cause deaths at 24 months(24 months)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
研究点 (1)
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