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

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.

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Publication Details

Journal
Nature Medicine
Published
2024-09-02
DOI
https://doi.org/10.1038/s41591-024-03243-9
Citations
31
Primary Topic
Cardiovascular Issues in Pregnancy
Type
article
Field-Weighted Citation Impact
12.46

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article

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

Jennifer Dugan, James Ayodele Ogunmodede, Demilade Adedinsewo, Paul A. Friedman et al.
31 citations
Nature Medicine
Cardiovascular Issues in Pregnancy
12.46
article

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

Jennifer Dugan, James Ayodele Ogunmodede, Demilade Adedinsewo, Paul A. Friedman, Rickey E. Carter, Sabrina D. Phillips, Temitope Adeolu, Kamilu Musa Karaye, Okechukwu S. Ogah, Francisco Lopez‐Jimenez, Francisca Inofomoh, Olusoji Jagun, Cynthia Yohanna, Peter A. Noseworthy, Zachi Itzhak Attia, Amam Mbakwem, Emily E. Sharpe, Sabiu M. Hamza, Andrea Carolina Morales-Lara, Bosede Bukola Afolabi, Oyewole A. Kushimo, Mikolaj A. Wieczorek, Mohamad H. Yamani, Gbolahan Obajimi, Patrick W. Johnson, Yvonne Butler Tobah, Xiaoxi Yao, Kehinde F. Ibiyemi, Hadijat Olaide Raji, Sadiq Hassan Ringim, Isiaka Alfa, Hanna J. Sledge, Abdullahi A. Habib, Olugbenga Oluseun Saanu, K Venkatachalam, Sule Abdullahi Gaya, Carl H. Rose
article en
31 citations

Abstract

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.

Nature MedicineVol. 30(10)
University of Ilorin (NG), University of Ibadan (NG), University of Lagos (NG), University College Hospital, Ibadan (NG), Lagos University Teaching Hospital (NG), Jacksonville College (US), WinnMed (US), Mayo Clinic in Arizona (US), Mayo Clinic in Florida (US), Olabisi Onabanjo University Teaching Hospital (NG), Aminu Kano Teaching Hospital (NG), University of Ilorin Teaching Hospital (NG), Olabisi Onabanjo University (NG), Bayero University Kano (NG)
National Institutes of Health, Center for Clinical and Translational Science, Mayo Clinic, Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston
Openalex Percentile: Top 1%
Cardiovascular Issues in Pregnancy
12.46
DOIOpen Access PDFOpenAlex
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