Actively Recruiting
Artificial Intelligence Scalable Solution for ST Myocardial Infarction (ASSIST): Cross-sectional Study
Led by Idoven 1903 S.L. · Updated on 2026-03-31
500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of Willem174, a cloud-based and AI-powered electrocardiogram (ECG) analysis platform, in detecting Acute Myocardial Infarction (AMI). This observational, multicenter study aims to compare the AI platform's ability to identify ECG patterns linked to AMI against human ECG interpretation, focusing on improving the speed and accuracy of diagnosis for acute coronary syndrome, especially ST-elevation myocardial infarction (STEMI). The study collects digitally stored 12-lead ECG traces and corresponding angiographic and clinical data from patients before invasive coronary angiography. Willem174 is designed to support physicians by reducing diagnosis time and workload, identifying subtle ECG patterns associated with high-risk coronary anatomy, and helping differentiate between STEMI, non-ST-elevation myocardial infarction (NSTEMI), and unstable angina. The goal is to improve early identification of patients with occlusion myocardial infarction and prevent unnecessary catheterization lab activations. Participants undergo a single baseline visit during which device performance and time assessments are made. Data collection includes analysis of ECGs and clinical information to evaluate the AI platform's diagnostic accuracy and timing compared to standard human interpretation. The study duration extends until May 2026, with no additional treatment or interventions required beyond data gathering and analysis at enrollment.
CONDITIONS
Brief Title
Artificial Intelligence Scalable Solution for ST Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Digitally stored 12-lead ECG traces available before invasive coronary angiography
- Available angiographic and clinical data
You will not qualify if you...
- ECGs with poor signal quality
- No digitally stored 12-lead ECG traces before coronary angiography
- Previous coronary events such as AMI or coronary revascularizations
- Missing clinical or angiographic data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a baseline visit where ECG data and clinical information are collected to support the development of an AI tool for accurate acute myocardial infarction diagnosis.
1 baseline visit (in-person)
Duration - Up to study completion in May 2026
Participants' ECG and angiographic data are observed and analyzed to evaluate device performance and time assessment outcomes after the baseline visit.
No additional visits required
Trial Site Locations
Total: 5 locations
1
Unidade Local de Saúde de São José
Lisbon, Portugal, 1169-056
Actively Recruiting
2
Unidade Local de Saúde de Lisboa Ocidental
Lisbon, Portugal, 1449-005
Actively Recruiting
3
Germans Trias i Pujol University Hospital
Barcelona, Spain, 08916
Actively Recruiting
4
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
5
La Paz University Hospital
Madrid, Spain, 28046
Actively Recruiting
Research Team
M
Manuel Marina-Breysse, MSc, MD
J
José María Lillo, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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