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Randomized Controlled Trials Evaluating Artificial Intelligence in Cardiovascular Care: A Systematic Review.

Dor Hadida Barzilai1, Karin Sudri1, Gal Goshen1

  • 1ARC Innovation Center, Sagol AI Hub, Sheba Medical Center, Ramat Gan, Israel.

JACC. Advances
|September 25, 2025
PubMed
Summary
This summary is machine-generated.

Artificial intelligence (AI) shows potential in cardiology, improving early detection and accuracy. More high-quality randomized controlled trials are needed to confirm AI

Keywords:
artificial intelligencecardiovascular careclinical outcomemachine learningrandomized controlled trialsystematic review

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Area of Science:

  • Cardiology
  • Medical Artificial Intelligence
  • Health Informatics

Background:

  • Artificial intelligence (AI) demonstrates significant potential for transforming healthcare, especially within cardiology.
  • A notable gap exists in high-quality evidence regarding AI's impact on critical clinical outcomes in cardiovascular medicine.

Purpose of the Study:

  • To systematically review and synthesize evidence from randomized controlled trials (RCTs) on AI applications in cardiology.
  • To evaluate the impact of AI interventions on key clinical outcomes in cardiovascular care.

Main Methods:

  • A systematic review adhering to PRISMA guidelines was performed, searching major databases (MEDLINE, Web of Science, Cochrane Library) up to November 2024.
  • Included RCTs compared machine learning models against traditional methods in cardiovascular care.
  • Primary outcomes focused on patient-important metrics; secondary outcomes assessed time and resource savings.

Main Results:

  • Eleven RCTs published between 2021 and 2024 met the inclusion criteria, with 81.2% being multicenter studies.
  • AI application led to improvements in clinical events in 45.5% of studies, enhanced diagnostic accuracy and early detection in 54.5%, and improved resource utilization in 27.3%.

Conclusions:

  • AI holds considerable promise for advancing cardiovascular care by enhancing early detection, diagnostic precision, and resource efficiency.
  • The current limited number of RCTs underscores the necessity for more rigorous studies to validate AI's efficacy across diverse cardiovascular clinical domains.