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临床试验/NCT06270927
NCT06270927进行中(未招募)不适用

• Code Stroke Imaging (CSI): MRI Or CT As First Scan For Acute Stroke Evaluation And Management

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年10月23日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrienne Dula

Assistant Professor of Neurology

University of Texas at Austin

研究点 (2)

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