Evidence map›Paper›PMID 39223284›Full record

Trial reportNature medicine2024

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

Demilade A Adedinsewo, Andrea Carolina Morales-Lara, Bosede B Afolabi, Oyewole A Kushimo, Amam C Mbakwem, Kehinde F Ibiyemi, James Ayodele Ogunmodede, Hadijat Olaide Raji, Sadiq H Ringim, Abdullahi A Habib and 28 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05438576 (Screening for Peripartum Cardiomyopathies Using Artificial Intelligence), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05438576 nacompletednot on this map

Screening for Peripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) in Nigeria

TypeinterventionalSponsorMayo ClinicRan2022 to 2024Enrolled1,232ConditionsCardiomyopathy, Pregnancy RelatedArmsDigital stethoscope electrocardiogram
3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

  1. Review
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  7. ESC guidelines 2025 on cardiovascular disease and pregnancy: considerations and future perspectives.European heart journal supplements : journal of the European Society of Cardiology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors.

Demilade A AdedinsewoDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA. adedinsewo.demilade@mayo.edu.ORCID http://orcid.org/0000-0002-8629-2029
Andrea Carolina Morales-LaraDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA.
Bosede B AfolabiDepartment of Obstetrics and Gynaecology, College of Medicine and Centre for Clinical Trials, Research and Implementation Science, University of Lagos, Lagos, Nigeria.ORCID http://orcid.org/0000-0002-7511-7567
Oyewole A KushimoCardiology Unit, Department of Medicine, Lagos University Teaching Hospital, Lagos, Nigeria.ORCID http://orcid.org/0000-0002-0760-8014
Amam C MbakwemCardiology Unit, Department of Medicine, Lagos University Teaching Hospital, Lagos, Nigeria.
Kehinde F IbiyemiDepartment of Obstetrics & Gynaecology, University of Ilorin Teaching Hospital, Ilorin, Nigeria.ORCID http://orcid.org/0000-0002-0125-7276
James Ayodele OgunmodedeDepartment of Medicine, University of Ilorin, Ilorin, Nigeria.
Hadijat Olaide RajiDepartment of Obstetrics & Gynaecology, University of Ilorin Teaching Hospital, Ilorin, Nigeria.ORCID http://orcid.org/0000-0003-4859-5405
Sadiq H RingimDepartment of Medicine, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria.ORCID http://orcid.org/0000-0002-5595-195X
Abdullahi A HabibDepartment of Obstetrics and Gynaecology, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria.
Sabiu M HamzaDepartment of Medicine, Rasheed Shekoni Specialist Hospital, Dutse, Nigeria.ORCID http://orcid.org/0000-0001-5780-6070
Okechukwu S OgahDepartment of Medicine, University of Ibadan, Oyo, Nigeria.
Gbolahan ObajimiDepartment of Obstetrics and Gynaecology, University College Hospital Ibadan, Oyo, Nigeria.
Olugbenga Oluseun SaanuDepartment of Obstetrics and Gynaecology, University College Hospital Ibadan, Oyo, Nigeria.
Olusoji E JagunDepartment of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.
Francisca O InofomohCardiology Unit, Department of Medicine, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.ORCID http://orcid.org/0000-0003-1851-8724
Temitope AdeoluCardiology Unit, Department of Medicine, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.
Kamilu M KarayeDepartment of Medicine, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.ORCID http://orcid.org/0000-0001-7992-2398
Sule A GayaDepartment of Obstetrics and Gynaecology, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.
Isiaka AlfaDepartment of Medicine, Bayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.
Cynthia YohannaLakeside Healthcare at Yaxley, the Health Centre, Peterborough, United Kingdom.
K L VenkatachalamDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA.
Jennifer DuganDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Xiaoxi YaoDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-9906-7106
Hanna J SledgeDepartment of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA.
Patrick W JohnsonDepartment of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA.
Mikolaj A WieczorekDepartment of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA.
Zachi I AttiaDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0002-9706-7900
Sabrina D PhillipsDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA.
Mohamad H YamaniDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA.
Yvonne Butler TobahDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0002-0665-1045
Carl H RoseDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA.
Emily E SharpeDepartment of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0003-4232-0718
Francisco Lopez-JimenezDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Paul A FriedmanDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-5052-2948
Peter A NoseworthyDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0002-4308-0456
Rickey E CarterDepartment of Quantitative Health Sciences, Mayo Clinic, Jacksonville, FL, USA.
SPEC-AI Nigeria Investigators

Funding

Mayo Clinic Center for Clinical and Translational Science (CCaTS UL1 Supplement - Dr. Timothy Curry)UL1TR002377 · NCATS · MAYO CLINIC ROCHESTER · PI VESNA D GAROVIC · 2017 to 2026
$78.4M
Mayo Clinic Building Interdisciplinary Research Careers in Women’s HealthK12AR084222 · NIAMS · MAYO CLINIC ROCHESTER · PI KANTARCI, KEJAL · 2023 to 2024
$733k
NCATS NIH HHS UL1 TR002377NIAMS NIH HHS K12 AR084222
6 · The paper itself

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.

Indexed as

Artificial IntelligenceCardiomyopathiesEchocardiographyAdultElectrocardiographyFemaleHumansMass ScreeningNigeriaPregnancyPregnancy Complications, CardiovascularVentricular Dysfunction, Left

Identifiers

PMID39223284
PMCPMC11485252

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.