Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 2,705
- 试验地点
- 1
- 主要终点
- Percentage of subjects to be diagnosed with SHD (structural heart disease)
研究概览
简要总结
The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>18 years of age)
- •Echocardiogram is not clinically indicated
排除标准
- •Prior history of congenital or acquired SHD, as defined by the following
- •Aortic Stenosis:
- •Heart Failure
- •Left Ventricular Dysfunction
- •Cardiac Amyloidosis
- •Hypertrophic Cardiomyopathy (HCM)
- •Rheumatic Heart Disease
- •Congenital Heart Disease
- •Recent (within last 12 months) echocardiogram
- •Scheduled clinically indicated future echocardiogram
- •Inability to provide informed consent to participate in the study
研究组 & 干预措施
Integrated pathway
干预措施: AI-ECG (artificial intelligence-enabled electrocardiogram) (Diagnostic Test)
Integrated pathway
干预措施: Focus Screening (focused cardiac ultrasonography) (Diagnostic Test)
Standard of Care pathway
结局指标
主要结局
Percentage of subjects to be diagnosed with SHD (structural heart disease)
时间窗: Baseline, 6 months, 1 year
Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy.
Positive predictive value (PPV)
时间窗: Baseline, 6 months, 1 year
Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis.
次要结局
- Number of deaths(1 year)
- Number of adverse cardiovascular events(1 year)
- Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)(Baseline, 6 months,1 year)
- Percentage of subjects to be diagnosed with cardiac amyloidosis(Baseline, 6 months,1 year)
- Percentage of subjects to be diagnosed with aortic stenosis(Baseline, 6 months,1 year)
- Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy(Baseline, 6 months,1 year)