ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Sensitivity of AK-AVS Algorithm for Detection of Moderate-to-Severe Aortic Stenosis as Confirmed by Echocardiography
研究概览
简要总结
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been diagnosed. The main question it aims to answer is if AK-AVS can correctly identify participants who have undiagnosed moderate-to-severe aortic stenosis, based on a routine heart tracing (electrocardiogram).
Approximately 4,000 electrocardiograms (ECGs) already collected as part of routine primary care, urgent care, or emergency room visits will be reviewed by the AK-AVS algorithm. Patients whose ECGs are flagged as showing a possible sign of aortic stenosis will be invited to complete a symptom questionnaire, a physical exam, and heart ultrasound (echocardiogram) to confirm whether aortic stenosis is present.
详细描述
This is a prospective, single-arm cohort study which screens approximately 4,000 de-identified 12-lead ECGs by the AK-AVS algorithm. Participants whose ECGs are flagged as positive are approached for consent and undergo a clinical evaluation. Point-of-care ultrasound is additionally performed for the first 10 patients. Confirmatory echocardiography is obtained when clinically indicated by this evaluation, and participants with confirmed AS or other clinically significant incidental findings are referred to the Heart Team for evaluation.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ECGs from primary care or ER visits
- •ECGs must include all relevant parameters for AK-AVS intake
- •Patients aged 65 and older at the time of the ECG
- •Subgroup analysis:
- •Patients with Insulin Resistance (pre-diabetic), Diabetes Mellitus, and Chronic Kidney Disease
- •Patients with hypertension
排除标准
- •ECG Poor Quality (as indicated by cardiology information system)
- •Patients already seen by cardiology, to effectively exclude:
- •Pacemaker / Paced rhythm Ejection fraction (EF) less than 40% Left ventricular hypertrophy (LVH) Prior diagnosis of Aortic Stenosis Prior diagnosis of heart failure Prior myocardial infraction (MI) Prior cardiac surgery
结局指标
主要结局
Sensitivity of AK-AVS Algorithm for Detection of Moderate-to-Severe Aortic Stenosis as Confirmed by Echocardiography
时间窗: Through study completion, an average of 6 months
Proportion of participants with an echocardiogram-confirmed diagnosis of moderate-to-severe aortic stenosis among those with a positive result from the AK-AVS algorithm, calculated with a 95% confidence interval
Positive Predictive Value of AK-AVS Algorithm-Positive Results as Confirmed by Echocardiography
时间窗: Through study completion, approximately 6 months
Proportion of algorithm-positive results confirmed as true moderate-to-severe aortic stenosis by echocardiogram, out of all algorithm-positive results evaluated
次要结局
- Relation of False-Positive AK-AVS Results to Other Cardiac Pathologies(Through study completion, an average of 6 months)
- Susceptibility of False-Positive AK-AVS Results to Future Clinically Relevant Aortic Stenosis(Through study completion, an average of 6 months)
- Rate of Clinically Significant Incidental Cardiac Findings on Echocardiography(Through study completion, an average of 6 months)
- Proportion of Confirmed Aortic Stenosis Cases with Absent Murmur(Through study completion, an average of 6 months)
- Proportion of Confirmed Aortic Stenosis Cases with Absent AS Symptoms(Through study completion, an average of 6 months)
- Proportion of Confirmed Aortic Stenosis Cases with Confounding Conditions Affecting Murmur Detection(Through study completion, an average of 6 months)
- Diagnostic Concordance of Point-of-Care Ultrasound with Echocardiography for Ruling Out Aortic Stenosis(Up to 2 months from study initiation)
- Time to Diagnosis of Aortic Stenosis from Initial Electrocardiogram(From date of initial ECG to date of confirmatory diagnosis, assessed up to 12 months)