Artificial Intelligence Scalable Solution for ST Myocardial Infarction

NCT06939738 | Completed

• 1 other identifier: ASSIST_01
• Study Type: observational
• Target: 489
• Locations: 2 countries
• Sites: 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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction (AMI); STEMI; NSTEMI; Occlusion Myocardial Infarction (OMI); AI-based ECG analysis

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Idoven 1903 S.L.: lead

Study Sites (5)

Unidade Local de Saúde de São José

Lisbon, 1169-056, Portugal

Location

Unidade Local de Saúde de Lisboa Ocidental

Lisbon, 1449-005, Portugal

Location

Germans Trias i Pujol University Hospital

Barcelona, 08916, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Alfonso Jurado, MD, PhD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

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: June 15, 2026
• Study Completion: June 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

PT (2); ES (3)