• Code Stroke Imaging (CSI): MRI Or CT As First Scan For Acute Stroke Evaluation And Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- compliance
研究概览
简要总结
The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort.
详细描述
The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort.
All patients will receive standard-of-care therapy and management based on AHA/ASA clinical practice guidelines. For patients with emergent large vessel occlusions, this will include adjuvant endovascular therapy if criteria, as stipulated in the guideline, are met. Although this is referred to as a prospective study, no data collection will occur until after standard of care procedures.
Population: "Code-Stroke" (potentially-treatable) patients, defined as patients presenting with clinical syndrome suggestive of stroke within 24-hours of time last known well will be included.
Setting: four certified stroke centers (Ascension Seton Williamson, Ascension Seton Medical Center, Ascension Seton Hayes, and Dell Seton Medical Center)
Rationale: There is current equipoise in selection of first scan modality for code stroke. The time-dependent efficacy of treatment with thrombolytics increases diagnostic burden on the stroke team, particularly less experienced providers. In efforts to minimize door to needle time (DTN), stroke mimics may be inadvertently treated with thrombolytics, particularly when insensitive diagnostics are used. The investigators plan to examine feasibility of comparing CT-first versus MR-first strategies to guide the development of a future large multicenter comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Time last known well to presentation ≤ 24 hours
- •Code-stroke (suspected treatable ischemic stroke) called prior to or upon arrival to Emergency Department
- •Presenting to Emergency Department for first time during study period
排除标准
- •Transfer patients
- •Contraindication for brain perfusion scan
- •Prior inclusion in study
研究组 & 干预措施
MRI
patients assigned to MRI
干预措施: MRI (Diagnostic Test)
MRI
patients assigned to MRI
干预措施: CT (Diagnostic Test)
CT
patients assigned to CT
干预措施: MRI (Diagnostic Test)
CT
patients assigned to CT
干预措施: CT (Diagnostic Test)
结局指标
主要结局
compliance
时间窗: over 12 weeks for phase one with week-by-week randomization to imaging modality, then 2 weeks of randomization per-patient
adherence to assigned first-scan imaging modality quantified as number of cross-overs (i.e., MRI scheduled but CT performed) relative to the sample size.
compliance
时间窗: Two phases will be included. Phase A: 12 weeks of cluster randomization with the initiation of each site staggered by 1 week, for a total of 15 weeks Phase B: 5 weeks of per-patient randomization Total time for enrollment: 20 weeks
adherence to assigned first-scan imaging modality quantified as number of cross-overs (i.e., MRI scheduled but CT performed) relative to the sample size.
次要结局
未报告次要终点
研究者
Adrienne Dula
Assistant Professor of Neurology
University of Texas at Austin
