Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 19,300
- 试验地点
- 1
- 主要终点
- Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
研究概览
简要总结
A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Adolescents and young adults:
- •Inclusion Criteria:
- •Enrollment in a high-school, college or a resident in MN during the study period
- •Age 18-29 years
- •Informed consent (and assent for minors)
排除标准
- •Presence of a pacemaker or defibrillator
- •Inability to obtain a quality ECG tracing
- •Community dwelling adults:
- •Inclusion Criteria:
- •Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))
- •Exclusion Criteria:
- •Inability to provide informed consent to participate in the study
- •Pregnant women:
- •Inclusion Criteria:
- •Adult female aged 18 to 49 years
- •Pregnant at the time of enrollment
- •Receiving obstetric care at identified study site(s)
- •Willing and able to provide informed consent
- •Exclusion Criteria:
- •Inability to provide consent
研究组 & 干预措施
Pregnant women
干预措施: Focused Cardiac Ultrasound (Diagnostic Test)
Pregnant women
干预措施: 6-Lead AI-ECG (Diagnostic Test)
Pregnant women
干预措施: 12-Lead AI-ECG (Diagnostic Test)
Adolescents and young adults
干预措施: Focused Cardiac Ultrasound (Diagnostic Test)
Adolescents and young adults
干预措施: 12-Lead AI-ECG (Diagnostic Test)
Community dwelling adults
干预措施: 12-Lead AI-ECG (Diagnostic Test)
Community dwelling adults
干预措施: Focused Cardiac Ultrasound (Diagnostic Test)
Community dwelling adults
干预措施: 6-Lead AI-ECG (Diagnostic Test)
Adolescents and young adults
干预措施: 6-Lead AI-ECG (Diagnostic Test)
结局指标
主要结局
Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
时间窗: Baseline
The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.
Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)
时间窗: Baseline
Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF \<50%, \>moderate right ventricular systolic dysfunction, \>moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure \> 50 mmHg), or elevated left-sided filling pressure.
Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)
时间窗: Baseline
Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction \[LVEF\] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension \[right ventricular systolic pressure \> 50 mmHg\], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.
次要结局
- Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)(Baseline)
- Number of non-cardiac adverse events (Pregnant Women)(Baseline)
- Number of false positive AI-ECG Results (Adolescents and young adults)(Baseline)
- Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)(Baseline)
- Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)(Baseline)
- Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)(Baseline)
- Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)(Baseline)
- Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)(Baseline)
- Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)(Baseline)
研究者
Paul A. Friedman
Principal Investigator
Mayo Clinic
