Artificial intelligence guided screening for cardiomyopathies in an obstetric population: a pragmatic randomized clinical trial.

Autor: Adedinsewo DA; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA. adedinsewo.demilade@mayo.edu., Morales-Lara AC; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA., Afolabi BB; Department of Obstetrics and Gynaecology, College of Medicine and Centre for Clinical Trials, Research and Implementation Science, University of Lagos, Lagos, Nigeria., Kushimo OA; Cardiology Unit, Department of Medicine, Lagos University Teaching Hospital, Lagos, Nigeria., Mbakwem AC; Cardiology Unit, Department of Medicine, Lagos University Teaching Hospital, Lagos, Nigeria., Ibiyemi KF; Department of Obstetrics & Gynaecology, University of Ilorin Teaching Hospital, Ilorin, Nigeria., Ogunmodede JA; Department of Medicine, University of Ilorin, Ilorin, Nigeria., Raji HO; Department of Obstetrics & Gynaecology, University of Ilorin Teaching Hospital, Ilorin, Nigeria., Ringim SH; Department of Medicine, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria., Habib AA; Department of Obstetrics and Gynaecology, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria., Hamza SM; Department of Medicine, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria., Ogah OS; Department of Medicine, University of Ibadan, Oyo, Nigeria., Obajimi G; Department of Obstetrics and Gynaecology, University College Hospital Ibadan, Oyo, Nigeria., Saanu OO; Department of Obstetrics and Gynaecology, University College Hospital Ibadan, Oyo, Nigeria., Jagun OE; Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria., Inofomoh FO; Cardiology Unit, Department of Medicine, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria., Adeolu T; Cardiology Unit, Department of Medicine, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria., Karaye KM; Department of Medicine, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria., Gaya SA; Department of Obstetrics and Gynaecology, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria., Alfa I; Department of Medicine, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria., Yohanna C; Lakeside Healthcare at Yaxley, the Health Centre, Peterborough, United Kingdom., Venkatachalam KL; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA., Dugan J; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Yao X; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA., Sledge HJ; Department of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA., Johnson PW; Department of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA., Wieczorek MA; Department of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA., Attia ZI; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Phillips SD; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA., Yamani MH; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA., Tobah YB; Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA., Rose CH; Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA., Sharpe EE; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA., Lopez-Jimenez F; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Friedman PA; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Noseworthy PA; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA., Carter RE; Department of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA.
Jazyk: angličtina
Zdroj: Nature medicine [Nat Med] 2024 Sep 02. Date of Electronic Publication: 2024 Sep 02.
DOI: 10.1038/s41591-024-03243-9
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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