Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Number of First-Degree Relatives to complete the AI-ECG
研究概览
简要总结
The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 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
- •Male or female age ≥ 18 years
- •Confirmed diagnosis of DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient
- •Must have at least one living ≥ 18 years FDR
- •Able to provide informed consent
- •Inclusion Criteria (FDR)
- •Male or female age ≥ 18 years who are first-degree relatives of patients with DCM
- •Proband has provided informed consent
- •FDR able to provide informed consent
- •Access to a smartphone or digital tablet with cellular data or Wi-Fi access
排除标准
- •DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination
- •Proband has previously informed FDR to undergo cardiac screening
- •Ischemic cause of reduced LVEF
- •evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease
- •history of acute coronary syndromes (STEMI, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or LAD or ≥75% stenosis of 2 major epicardial vessels on angiogram
- •Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
- •Congenital structural heart disease
- •Severe and untreated or untreatable hypertension
- •Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload
- •Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug
- •(CPC Participants only) Home address outside of traveling range
- •Exclusion Criteria (FDR)
- •Previously informed about cardiac screening or has completed cardiac screening by TTE
- •Previously diagnosed with reduced LVEF
- •(CPC Participants only) Home address outside of traveling range
研究组 & 干预措施
First degree relatives
Subjects who are first-degree relatives of patients with DCM
干预措施: KardiaRx ECG Screening and AI interpretation of ECG (Diagnostic Test)
DCM (Dilated Cardiomyopathy) Patients
Subjects who are diagnosed with DCM (dilated cardiomyopathy).
干预措施: KardiaRx ECG Screening and AI interpretation of ECG (Diagnostic Test)
结局指标
主要结局
Number of First-Degree Relatives to complete the AI-ECG
时间窗: Baseline
Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm.
Number of First-Degree relatives to complete cardiac screening
时间窗: Baseline
The following screening procedures will be considered a valid cardiac screening attempt: * Scheduled or Completed TTE * Scheduled or completed clinician visit for the purposes of generating a cardiac evaluation
次要结局
- Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%(Baseline)
研究者
Naveen L. Pereira
Principal Investigator
Mayo Clinic