Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Time to Imaging
研究概览
简要总结
Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Admitted patients who require LA imaging prior to cardioversion
- •Age ≥18 years old
- •Able and willing to comply with the study procedures
排除标准
- •Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema)
- •Unwillingness or inability to provide informed consent
- •Contraindication to Cardiac CT
- •Severe renal insufficiency(GFR< 45ml/min)
- •Allergy to intravenous contrast agents
- •Contraindications to radiation exposure (for example, pregnancy)
- •Inability to perform 20-second breath-hold
- •Contraindication to TEE
- •Unrepaired tracheoesophageal fistula
- •Esophageal obstruction or stricture
- •Perforated hollow viscus
- •Poor airway control
- •Severe respiratory depression
- •Uncooperative, unsedated patient
研究组 & 干预措施
TEE arm
TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast.
干预措施: Transesophageal Echocardiography (TEE) (Diagnostic Test)
CCT arm
As per local protocol, a non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using a tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after the initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE.
干预措施: Contrast enhanced ECG-gated cardiac CT (CCT) (Diagnostic Test)
CCT arm
As per local protocol, a non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using a tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after the initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE.
干预措施: Transesophageal Echocardiography (TEE) (Diagnostic Test)
结局指标
主要结局
Time to Imaging
时间窗: From admission to imaging/spontaneous cardioversion, up to approximately 30 days.
This outcome was measured by calculating the time between admission and imaging.
次要结局
- Time to Cardioversion(From admission to cardioversion, up to approximately 30 days)