Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms: a Pragmatic Randomized Clinical Trial (DECISION)

What this Trial Is About

The DECISION trial investigates whether an artificial intelligence (AI) system called Willem123 can improve the detection of heart failure (HF) in primary care. The study compares AI-assisted electrocardiogram (ECG) interpretation with standard ECG evaluation to see if the AI approach leads to better diagnosis and clinical outcomes. It focuses on patients suspected of having HF or those at high risk, aiming to enhance early detection and reduce missed cases. Participants are randomly assigned to one of two groups: one group receives ECG analysis with the support of the Willem123 AI platform, while the other group undergoes standard ECG assessment without AI assistance. The AI provides detailed interpretation of over 80 cardiac patterns to help clinicians identify heart abnormalities. The study takes place in multiple primary care centers in Spain and Sweden and includes follow-up assessments to evaluate healthcare use and physician satisfaction. During the study, participants undergo electrocardiograms and transthoracic echocardiograms (TTE) to confirm heart function. The primary outcome measures the AI device's diagnostic accuracy for HF seven days after screening. Secondary outcomes include performance in patients at cardiovascular risk without symptoms and assessments six months after the ECG. Researchers also monitor clinical outcomes and collect feedback from healthcare providers about the AI tool's usability.

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)