Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study

Обзор

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.

Вмешательства

• Устройство Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus
  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.
• Устройство Delayed Gated CT Scan for Left Atrial Appendage Thrombus
  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.

Первичные конечные точки

• Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans [Срок оценки: 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.]

Вторичные конечные точки (1)

• Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection. [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• North Shore University Hospital — Manhasset

Публикации

• 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. PMID 33161849
• 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. PMID 29622180
• 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. PMID 26930405
• 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. PMID 23682043
• 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. PMID 33216141

Идентификаторы

NCT: NCT07647939 · 24-0413-North Shore University

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗