Artificial Intelligence Scalable Solution for ST Myocardial Infarction
ASSIST
1 other identifier
observational
500
2 countries
5
Brief Summary
The ASSIST clinical study is an observational, multicenter study to assess the performance of a cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, developed to detect Acute Myocardial Infarction (AMI). The main objectives are to compare Willem™ performance to detect and triage ECG patterns associated with AMI compared with human ECG interpretation, and to assess the time periods for both approaches.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 31, 2026
December 1, 2025
1.1 years
April 15, 2025
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Device performance
Assessment of Willem™ diagnostic performance to detect Acute Myocardial Infarction (AMI) based on ECG analysis. The diagnostic performance metrics and their measurement units will be: * Accuracy, Sensitivity, and Specificity (%) * Positive Predictive Value (PPV) and Negative Predictive Value (NPV) (%) * F1-score (score from 0.0 to 1.0)
At the time of enrolment and throughout the baseline visit (single study visit)
Secondary Outcomes (1)
Time assessment
At the time of enrolment and throughout the baseline visit (single study visit)
Eligibility Criteria
Adult patients with suspected Acute Coronary Syndrome (ACS) presenting to the emergency department and subsequently referred for angiography at the Catheterization Laboratory of the participating sites.
You may qualify if:
- Age ≥ 18 years;
- Available digitally stored 12-lead ECG traces prior to invasive coronary angiography;
- Available angiographic and clinical data.
You may not qualify if:
- ECGs with poor signal quality;
- Lack of digitally stored 12-lead ECG traces prior to coronary angiography;
- Previous coronary events (AMI, coronary revascularizations);
- Non-available clinical or angiographic data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Idoven 1903 S.L.lead
Study Sites (5)
Unidade Local de Saúde de São José
Lisbon, 1169-056, Portugal
Unidade Local de Saúde de Lisboa Ocidental
Lisbon, 1449-005, Portugal
Germans Trias i Pujol University Hospital
Barcelona, 08916, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
La Paz University Hospital
Madrid, 28046, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfonso Jurado, MD, PhD
La Paz University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
April 23, 2025
Study Start
April 1, 2025
Primary Completion
April 30, 2026
Study Completion
May 1, 2026
Last Updated
March 31, 2026
Record last verified: 2025-12