Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 4
- 主要终点
- Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention
研究概览
简要总结
The Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke (CONTEST) aims at assessing the diagnostic value of transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE) with regards to treatment consequences in patients with acute ischemic stroke.
详细描述
For this purpose, the investigators will perform a prospective multicenter diagnostic comparative effectiveness study. Patients with acute stroke will be studied by both TTE and TEE. Patients with already defined stroke etiology and determined secondary prevention will be excluded from the trial. Treatment relevant diagnostic findings will be identified by a central endpoint adjudication committee. In order to demonstrate a hypothesized 2% absolute increase in the number of treatment relevant diagnostic findings by TEE as compared to TTE, 880 stroke patients will be enrolled in six German stroke centers. CONTEST will allow answering the question whether and for which group of stroke patients TEE is indicated in addition to TTE. By this, the study will provide evidence to guide justified recommendations for echocardiography in acute stroke patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke or transitory ischemic attack (TIA)
- •age ≥18 years
- •informed consent
排除标准
- •Patients with already defined stroke etiology and determined secondary prevention treatment strategy prior to echocardiography (e.g. atrial fibrillation, carotid artery stenosis, cervical artery dissection)
结局指标
主要结局
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention
时间窗: Inpatient treatment on a stroke unit usually <7 days
Treatment relevant diagnostic findings identified by a central endpoint adjudication committee comprising both cardiologists and neurologists.
次要结局
- Number of Patients With Change of Assessment of Stroke Etiology After TEE(Inpatient treatment on a stroke unit usually <7 days)