Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 3
- 主要终点
- Primary composite outcome
研究概览
简要总结
The goal of this randomized clinical trial is to learn whether patients with symptomatic atrial fibrillation or atrial flutter (AF) who require heart imaging to rule out a blood clot before cardioversion would benefit from cardiac computed tomography angiography (CCT) in the emergency department (ED) compared to current standard of care management.
This will be a multicenter trial evaluating whether CCT-facilitated cardioversion in the ED reduces hospital admission, reduces repeat presentations to hospital and improves patient quality of life compared to the current standard of care.
Participants will undergo CCT-facilitated cardioversion or be treated according to current standard of care while in the ED and complete quality of life questionnaires in the ED and follow-up at 30 days.
详细描述
Atrial fibrillation and atrial flutter (AF) are the most common cardiac arrhythmias worldwide resulting in frequent visits to the emergency department (ED). Some patients can undergo chemical or electrical cardioversion to restore their heart back to a sinus rhythm. However, if a patient is not on blood thinners and the duration of AF is prolonged then blood clots may form in the heart increasing the risk of stroke after cardioversion. Therefore, some patients must undergo heart imaging to rule out any blood clots before cardioversion is considered safe. Transesophageal echocardiography (TEE) is commonly used to rule out blood clots, but it is not readily available in all EDs often resulting in hospital admission to facilitate this test or deferring cardioversion until 3 weeks of blood thinners have been completed.
Cardiac computed tomography angiography (CCT) is a more readily available alternative to TEE that can be done rapidly in the ED. CCT has excellent sensitivity and specificity compared to TEE for identifying cardiac thrombus. If there is no thrombus detected on the CCT then patients could be immediately cardioverted to sinus rhythm thus avoiding an unnecessary hospital admission and reducing the symptom burden associated with remaining in AF.
This study is a multicenter randomized trial that will evaluate the effectiveness of using CCT facilitated cardioversion in the ED compared to current standard of care management.
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
- Single (Investigator)
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
- •Age ≥18 years old; and
- •Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism)
- •LA imaging required before cardioversion according to local clinical practice guidelines
排除标准
- •Patients with an indication for emergency cardioversion (e.g. hemodynamic instability (systolic blood pressure<90mmHg or signs of shock), cardiac ischemia (ongoing severe chest pain or marked ST depression on ECG >2mm), or pulmonary edema (significant dyspnea, crackles, or hypoxia)); or
- •Contraindication to CCT (renal insufficiency (eGFR< 45ml/min/1.73m2), allergy to intravenous contrast agents, pregnancy (contraindications to radiation exposure), or inability to perform 20-second breath-hold)
研究组 & 干预措施
Standard of Care
Patients in the control arm will be treated according to current standard of care as determined by the primary treating emergency department physician and may vary by institution and physician. Treatment in the standard of care group may include a rate control strategy with or without a planned cardioversion after 3 weeks of anticoagulation, deferring management for outpatient evaluation, request for TEE-facilitated cardioversion in the ED, or specialist consultation for further management or admission to hospital.
干预措施: Standard of care management (Other)
CCT-facilitated cardioversion arm
Patients in this arm will undergo cardiac computed tomography angiography (CCT) to evaluate for a left atrial/left atrial appendage (LA) thrombus. If the CCT shows no LA thrombus then the emergency department physician will be able to perform electrical and/or chemical cardioversion at their discretion. If the CCT shows a LA thrombus then cardioversion will be contraindicated and further management will be at the discretion of the treating physician.
干预措施: Cardiac computed tomography angiography (Diagnostic Test)
结局指标
主要结局
Primary composite outcome
时间窗: Randomization to 30 days
Using a hierarchical win ratio: 1. All-cause death 2. Stroke, transient ischemic attack, or systemic embolism 3. Admission to hospital for a cardiac or AF related reason 4. Repeat presentation to hospital for a cardiac or AF related reason 5. Improvement in AF Effect On Quality-Of-Life Questionnaire (AFEQT) quality of life greater than or equal to 5 points
次要结局
- Hospital admission for a cardiac or AF related reason(Randomization to 30 days)
- Normal sinus rhythm(Randomization to 30 days)
- Composite objective outcomes(Randomization to 30 days)
- All-cause death(Randomization to 30 days)
- Bleeding(Randomization to 30 days)
- Cardiovascular death(Randomization to 30 days)
- Stroke, transient ischemic attack, or systemic embolism(Randomization to 30 days)
- Repeat presentation to the emergency department(Randomization to 30 days)
- AFEQT quality of life(Randomization to 30 days)
- SF-36 quality of life(Randomization to 30 days)
- Admission to hospital for acute kidney injury(Randomization to 30 days)
- Length of stay in the emergency department(From time of arrival until time of discharge or admission (approximately 3 hours))