Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA.
Department of Obstetrics and Gynaecology, College of Medicine and Centre for Clinical Trials, Research and Implementation Science, University of Lagos, Lagos, Nigeria.
Nat Med. 2024 Oct;30(10):2897-2906. doi: 10.1038/s41591-024-03243-9. Epub 2024 Sep 2.
Nigeria has the highest reported incidence of peripartum cardiomyopathy worldwide. This open-label, pragmatic clinical trial randomized pregnant and postpartum women to usual care or artificial intelligence (AI)-guided screening to assess its impact on the diagnosis left ventricular systolic dysfunction (LVSD) in the perinatal period. The study intervention included digital stethoscope recordings with point of-care AI predictions and a 12-lead electrocardiogram with asynchronous AI predictions for LVSD. The primary end point was identification of LVSD during the study period. In the intervention arm, the primary end point was defined as the number of identified participants with LVSD as determined by a positive AI screen, confirmed by echocardiography. In the control arm, this was the number of participants with clinical recognition and documentation of LVSD on echocardiography in keeping with current standard of care. Participants in the intervention arm had a confirmatory echocardiogram at baseline for AI model validation. A total of 1,232 (616 in each arm) participants were randomized and 1,195 participants (587 intervention arm and 608 control arm) completed the baseline visit at 6 hospitals in Nigeria between August 2022 and September 2023 with follow-up through May 2024. Using the AI-enabled digital stethoscope, the primary study end point was met with detection of 24 out of 587 (4.1%) versus 12 out of 608 (2.0%) patients with LVSD (intervention versus control odds ratio 2.12, 95% CI 1.05-4.27; P = 0.032). With the 12-lead AI-electrocardiogram model, the primary end point was detected in 20 out of 587 (3.4%) versus 12 out of 608 (2.0%) patients (odds ratio 1.75, 95% CI 0.85-3.62; P = 0.125). A similar direction of effect was observed in prespecified subgroup analysis. There were no serious adverse events related to study participation. In pregnant and postpartum women, AI-guided screening using a digital stethoscope improved the diagnosis of pregnancy-related cardiomyopathy. ClinicalTrials.gov registration: NCT05438576.
尼日利亚是全世界报道的围产期心肌病发病率最高的国家。本开放性、实用性临床试验将妊娠和产后妇女随机分为常规护理组或人工智能（AI）指导筛查组，以评估其对围产期左心室收缩功能障碍（LVSD）诊断的影响。研究干预措施包括使用即时 AI 预测的数字听诊器记录和 12 导联心电图进行异步 AI 预测 LVSD。主要终点是在研究期间确定 LVSD。在干预组中，主要终点定义为通过 AI 阳性筛查确定的患有 LVSD 的参与者人数，经超声心动图证实。在对照组中，这是根据当前护理标准，通过临床识别和超声心动图记录 LVSD 的参与者人数。干预组的参与者在基线时进行了 AI 模型验证的确认性超声心动图检查。共有 1232 名（每组 616 名）参与者被随机分配，1195 名（587 名干预组和 608 名对照组）参与者于 2022 年 8 月至 2023 年 9 月在尼日利亚的 6 家医院完成了基线访视，并随访至 2024 年 5 月。使用人工智能驱动的数字听诊器，主要研究终点在 587 名患者中检测到 24 例（4.1%）与 608 名患者中的 12 例（2.0%）LVSD（干预组与对照组比值比 2.12，95%CI 1.05-4.27；P=0.032）。使用 12 导联 AI 心电图模型，在 587 名患者中检测到 20 例（3.4%）与 608 名患者中的 12 例（2.0%）LVSD（比值比 1.75，95%CI 0.85-3.62；P=0.125）。预先指定的亚组分析中观察到了类似的效果方向。研究参与没有与严重不良事件相关。在妊娠和产后妇女中，使用数字听诊器的 AI 指导筛查提高了妊娠相关性心肌病的诊断。临床试验注册：NCT05438576。
