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临床试验/NCT07351656
NCT07351656招募中不适用

Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 19,300 人开始时间: 2026年3月9日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Focused Cardiac Ultrasound (Diagnostic Test)

Pregnant women

Experimental

干预措施: 6-Lead AI-ECG (Diagnostic Test)

Pregnant women

Experimental

干预措施: 12-Lead AI-ECG (Diagnostic Test)

Adolescents and young adults

Experimental

干预措施: Focused Cardiac Ultrasound (Diagnostic Test)

Adolescents and young adults

Experimental

干预措施: 12-Lead AI-ECG (Diagnostic Test)

Community dwelling adults

Experimental

干预措施: 12-Lead AI-ECG (Diagnostic Test)

Community dwelling adults

Experimental

干预措施: Focused Cardiac Ultrasound (Diagnostic Test)

Community dwelling adults

Experimental

干预措施: 6-Lead AI-ECG (Diagnostic Test)

Adolescents and young adults

Experimental

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul A. Friedman

Principal Investigator

Mayo Clinic

研究点 (1)

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