Artificial Intelligence Scalable Solution for ST Myocardial Infarction (ASSIST)

March 30, 2026 updated by: Idoven 1903 S.L.

Artificial Intelligence Scalable Solution for ST Myocardial Infarction (ASSIST): Cross-sectional Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Delays in triage and diagnosis of patients presented with chest pain or other symptoms suggestive of Acute coronary syndrome (ACS) can be fatal. This study aims to improve those two aspects in acute ischemic disease care: reducing the delays to intervention and improving the accuracy of initial diagnosis, which are of paramount importance in cases of ACS, especially in ST-elevation myocardial infarction (STEMI). The former plays a critical role in minimizing in-hospital mortality rates, which have been shown to decrease proportionally with reduction of times to intervention. The latter relies on a correct interpretation of the ECG, first-line diagnostic tool in the assessment of patients with suspected ACS.

The current standard of care for ACS includes a 12-lead ECG that should be performed within the first 10 minutes from the first medical contact. The ECG must be interpreted by a qualified physician, who will alert the on-call cardiologist to confirm or not the activation of the "infarction code", based on the ECG and clinical presentation. Such activation will mainly entail immediate transfer of the patient to the nearest hospital with the possibility of emergency coronary angiography (if not present in the initial institution), and eventual percutaneous coronary intervention (PCI). Regarding the diagnosis of Acute Myocardial Infarction (AMI), an accurate and rapid interpretation of the first ECG is critical for the differential diagnosis between STEMI, NSTEMI or unstable angina; and follow the proper standard of care guidelines. The largest delays occurs between the first ECG and the transportation for the cardiac catheterization laboratory, which has prognostic implications.

In recent years, automatic digital tools based on artificial intelligence (AI) have been proposed as a solution to support physicians in the ECG interpretation, reducing their workload and time-to-diagnosis, suggesting the beneficial impact of AI-platforms for accurate diagnosis of AMI. In this setting, the AI-platforms should be able to automatically detect ECG patterns linked to unfavorable coronary anatomy and poor outcomes. It is also essential to have the capacity to identify more subtle ECG patterns, not obvious during physicians' interpretation, but indicating high-risk coronary anatomy. Additionally, the platform should assist the prediction of most severe coronary lesions, especially obstructive stenosis. This ability to detect coronary lesions could be useful in preventing unnecessary or premature activation of the catheterization laboratory, mainly in NSTEMI setting.

The ASSIST clinical study is a cross-sectional, multicenter study aiming to collect data to develop the Willem™ platform, an AI-based tool for ECG analysis. This plataform could improve the accuracy for AMI diagnosis, particularly the differentiation between STEMI and NSTEMI, and early identification of patients with Occlusion Myocardial Infarction (OMI).

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Manuel Marina-Breysse, MSc, MD
  • Phone Number: +34618103160
  • Email: m@idoven.ai

Study Locations

  • Portugal
      • Lisbon, Portugal, 1169-056
        • Recruiting
        • Unidade Local de Saúde de São José
        • Contact:
      • Lisbon, Portugal, 1449-005
  • Spain
      • Barcelona, Spain, 08916
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Madrid, Spain, 28046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Available digitally stored 12-lead ECG traces prior to invasive coronary angiography;
  • Available angiographic and clinical data.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device performance
Time Frame: At the time of enrolment and throughout the baseline visit (single study visit)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time assessment
Time Frame: At the time of enrolment and throughout the baseline visit (single study visit)
Assessment of the time needed for AMI diagnosis and for intervention (e.g. door-to-balloon time)
At the time of enrolment and throughout the baseline visit (single study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idoven 1903 S.L.

Investigators

  • Principal Investigator: Alfonso Jurado, MD, PhD, La Paz University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASSIST_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Grouped data corresponding to the clinical study objectives may be published at the end of the study. All data collected throughout the study would be included, since all clinical variables are collected per the standard of care and all relate to the two study objectives.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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