Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care
研究概览
简要总结
Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.
详细描述
The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age ≥65 with a current diagnosis or history of cancer.
- •Patients currently undergoing or history of chemotherapy, radiotherapy or cancer related surgeries will be included.
- •The age is restricted to ≥65 years because prevalence of AF is extremely low. .
排除标准
- •Known history of atrial fibrillation.
- •Non-English-speaking participants will not be enrolled
研究组 & 干预措施
Screen group
Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). If the mobile ECG shows possible AF or unclassified, then patients will undergo a 12-lead standard ECG during the same visit, read by a cardiologist, to verify the correct diagnosis.
干预措施: 30-second ECG using the Kardia Mobile (Diagnostic Test)
Usual Care
For patients in the usual care arm, medical record review will be done at end of study to assess for the newly diagnosed AF during the study period.
干预措施: routine care (Other)
结局指标
主要结局
The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care
时间窗: 6 MONTHS
To compare the incidence of newly diagnosed AF with point-of-care screening using a mobile, single-lead ECG versus usual care, in patients with a diagnosis of solid cancer. In this open-label, prospective pilot RCT, patients (n=480) with AF and solid cancer presenting for an outpatient visit will be randomized 1:1 to screening versus usual care. A 30-second screening ECG will be done using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad. The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care.
次要结局
- To determine the effect of screening-detected AF on initiation of anticoagulation.(6 MONTHS)