SPEC-AI Nigeria

Trial question

What is the role of artificial intelligence-guided screening for pregnancy-related cardiomyopathy in pregnant and postpartum women?

Study design

Multi-center

Open label

RCT

Population

1195 female patients.

Inclusion criteria: pregnant or postpartum (up to 12 months) women aged 18-49 years.

Key exclusion criteria: complex congenital heart disease; notable cardiac conduction abnormalities; inability to provide informed consent.

Interventions

N=587 AI-guided screening (artificial intelligence-guided screening for cardiomyopathy, using an artificial intelligence-enabled digital stethoscope and ECG).

N=608 usual care (standard 12-lead clinical ECG in addition to usual care as dictated by the managing physician).

Primary outcome

Detection of left ventricular systolic dysfunction, using an AI-enabled digital stethoscope in AI group

4.1%

4.1 %

3.1 %

2.0 %

1.0 %

0.0 %

AI-guided screening

Usual care

Significant increase ▲

NNT = 47

Significant increase in detection of LV systolic dysfunction, using an AI-enabled digital stethoscope in AI group (4.1% vs. 2%; OR 2.12, 95% CI 1.05 to 4.27).

Secondary outcomes

No significant difference in detection of LV systolic dysfunction, using an AI-enabled ECG in AI group (3.4% vs. 2%; OR 1.75, 95% CI 0.85 to 3.62).

No significant difference in adverse cardiovascular outcomes (9.5% vs. 8.7%; OR 1.1, 95% CI 0.74 to 1.64).

Significant increase in all-cause mortality (2% vs. 0.5%; HR 4.2, 95% CI 1.18 to 14.87).

Safety outcomes

No significant difference in adverse events.

Conclusion

In pregnant or postpartum (up to 12 months) women aged 18-49 years, AI-guided screening was superior to usual care with respect to detection of LV systolic dysfunction, using an AI-enabled digital stethoscope in AI group.

Reference

Demilade A Adedinsewo, Andrea Carolina Morales-Lara, Bosede B Afolabi et al. Artificial intelligence guided screening for cardiomyopathies in an obstetric population: a pragmatic randomized clinical trial. Nat Med. 2024 Oct;30(10):2897-2906.

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