Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study (ELATE-AF)
2026年6月9日 更新者：Northwell Health
This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation.
Detecting these clots is crucial before certain heart procedures to prevent stroke.
Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used.
This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye.
The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm).
The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself.
There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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Manhasset、New York、美国、11030
- North Shore University Hospital
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接触：
- Tabetha Garver-Mosher
- 电话号码：1514 516-562-0100
- 邮箱：tgarvermosher@northwell.edu
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接触：
- Ana Centeno Rahbani
- 邮箱：acentenorahb@northwell.edu
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首席研究员：
- Ramanak Mitra, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.
- Room air oxygen saturation above 92%
- Systolic blood pressure above 100 mm Hg
- Respiratory rate less than 24 breaths/min
Exclusion Criteria:
- Inability to personally give informed consent
- Pregnant or breastfeeding individuals
- Stroke like symptoms
- ECG criteria for ischemia or infarction
- Heart rate <40 or > 120 bpm (inclusive) or 3rd degree heart block
- Unable to lie flat for at least 10 minutes
- Unable to follow simple commands
- Northwell Health Employees.
- Non-English-speaking patients
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Delayed Un-gated CT Scan Arm
This arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage.
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Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed un-gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot.
No additional intravenous contrast will be given.
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实验性的：Delayed Gated CT Scan Arm
This arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage.
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Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot.
No additional intravenous contrast will be given.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans
大体时间：The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.
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The primary endpoint of this study is to test the hypothesis that less than or equal to 20% of the repeat CT scan (described above) will be indeterminate for the presence or absence of left atrial appendage thrombus.
Additionally, the proportion of indeterminate gated CT scans will be compared to the proportion of indeterminate ungated CT scans.
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The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection.
大体时间：The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate.
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The secondary outcome of this study will be calculation of the negative and positive predictive value of this additional CT scan for detection of left atrial appendage thrombus, in the study population.
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The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Senadeera SC, Palmer DG, Keenan R, Beharry J, Yuh Lim J, Hurrell MA, Mouthaan P, Fink JN, Wilson D, Lim A, Wu TY. Left Atrial Appendage Thrombus Detected During Hyperacute Stroke Imaging Is Associated With Atrial Fibrillation. Stroke. 2020 Dec;51(12):3760-3764. doi: 10.1161/STROKEAHA.120.030258. Epub 2020 Nov 9.
- Pathan F, Hecht H, Narula J, Marwick TH. Roles of Transesophageal Echocardiography and Cardiac Computed Tomography for Evaluation of Left Atrial Thrombus and Associated Pathology: A Review and Critical Analysis. JACC Cardiovasc Imaging. 2018 Apr;11(4):616-627. doi: 10.1016/j.jcmg.2017.12.019.
- Ng AC, Adikari D, Yuan D, Lau JK, Yong AS, Chow V, Kritharides L. The Prevalence and Incidence of Atrial Fibrillation in Patients with Acute Pulmonary Embolism. PLoS One. 2016 Mar 1;11(3):e0150448. doi: 10.1371/journal.pone.0150448. eCollection 2016.
- Shinkins B, Thompson M, Mallett S, Perera R. Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ. 2013 May 16;346:f2778. doi: 10.1136/bmj.f2778. No abstract available.
- Wang RC, Miglioretti DL, Marlow EC, Kwan ML, Theis MK, Bowles EJA, Greenlee RT, Rahm AK, Stout NK, Weinmann S, Smith-Bindman R. Trends in Imaging for Suspected Pulmonary Embolism Across US Health Care Systems, 2004 to 2016. JAMA Netw Open. 2020 Nov 2;3(11):e2026930. doi: 10.1001/jamanetworkopen.2020.26930.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年3月16日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.