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Myocardial Infarction (MI)TITAN-OMINCT07077057

Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

A study testing AI-assisted ECG interpretation (PMcardio) in people with Myocardial Infarction (MI) and Acute Coronary Syndrome (ACS), run by Cardiocentro Ticino at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AI-assisted ECG interpretation (PMcardio)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteSwitzerland
Study dates
23 Aug 2025to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms suspected of ongoing acute myocardial ischemia: Patients presenting with symptoms such as chest pain, dyspnoea, sweating, nausea or vomiting, pain radiating to the shoulder/arm/jaw/back, fatigue, or light-headedness
  • Age: Patients aged 18 years or older.
  • Informed Consent: Patients able to provide informed consent

Who cannot join

  • Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
  • Pregnancy or Lactation.
  • Legally incompetent to provide informed consent.
  • Symptoms onset>24 hrs prior to clinical presentation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting

  • Cardiocentro Ticino Institute

    Lugano, Canton Ticino, 6900

    Marco Valgimigli, MD, PhD, +41 91 8115363, marco.valgimigli@eoc.ch

    Andrea Milzi, MD, +41 91 8115385, andrea.milzi@eoc.ch

    Recruiting

Other trials in Switzerland

About this study

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria.

The main questions it aims to answer are:

Read more
  1. Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention?
  2. Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels?

Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines.

Participants will:

  1. Present with symptoms suggestive of ACS but without clear STEMI criteria
  2. Be randomized 1:1 to either AI-assisted or standard ECG interpretation
  3. Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels
Being tested
AI-assisted ECG interpretation (PMcardio)
Keywords
Occlusion Myocardial Infarction, Electrocardiogram, Artificial Intelligence
Medical subject headings
Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-assisted ECG interpretation (PMcardio)Diagnostic test

    Participants in the experimental arm will undergo 12-lead ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical, Slovakia). The AI algorithm analyzes ECG data in real time to detect patterns suggestive of occlusion myocardial infarction (OMI), including cases not meeting traditional ST-elevation myocardial infarction (STEMI) criteria. In the experimental arm, the AI output is provided immediately to the treating clinician and used as an adjunct to standard ECG interpretation to support timely diagnosis and management decisions.

Study groups in NCT07077057
Study groupRoleWhat they receive
AI-assisted ECG interpretationExperimentalParticipants will receive ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical). The AI output is made available to clinicians in real time, prior to diagnostic or therapeutic decisions, to facilitate earlier identification of occlusion myocardial infarction (OMI) and potentially expedite intervention.
Receives: Diagnostic Test: AI-assisted ECG interpretation (PMcardio)
Standard of CareNo interventionParticipants will receive standard ECG interpretation without AI support. Clinical decisions regarding diagnosis and treatment will follow usual care pathways, without influence from the AI tool. This arm serves as the comparator to evaluate the added value of AI integration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hierarchical primary endpoint

    The primary endpoint of the prospective phase, analysed hierarchically using the unmatched, unstratified win ratio, will be a composite of:

    • Cardiovascular mortality at 30 days.
    • Timely treatment of angiographically confirmed TIMI 0-1 occlusions, defined as insertion of the arterial sheath within 120 minutes from randomization.
    • Time-to-treatment of angiographically confirmed TIMI 0-1 occlusions.
    • Peak high- hsTnT levels in ng/mL as a surrogate measure of infarct size. Time of coronary intervention will be defined as time from randomisation to insertion of the arterial sheath. Peak hsTnT is defined as the maximum level of hsTnT within 48h from randomization or within 48 hours from intervention if percutaneous coronary intervention took place later than 24 hours from randomization.

    Measured: 30 days

Secondary outcomes (21)

  1. Cardiovascular mortality at 30 days

    Cardiovascular mortality at 30 days

    Measured: 30 days

  2. Timely treatment of TIMI 0-1 occlusions

    Timely treatment is defined as arterial sheath insertion within 120 minutes of randomization

    Measured: Periprocedural

  3. Time-to-treatment of TIMI 0-1 occlusions

    Expressed in minutes from time of randomization

    Measured: Periprocedural

  4. Peak hsTnT levels

    Peak hsTnT is defined as the maximum level of hsTnT within 48h from randomization or within 48 hours from intervention if percutaneous coronary intervention took place later than 24 hours from randomization.

    Measured: 48 hours from randomization or intervention

  5. Major adverse cardiovascular events (MACE) at follow-up

    Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, or stroke at follow up (30-days, 1 year, 3/5/10 years)

    Measured: up to 10 years

  6. Cardiovascular death at follow-up

    Cardiovascular death at follow up (30-days, 1 year, 3/5/10 years)

    Measured: up to 10 years

  7. Myocardial infarction at follow-up

    Myocardial infarction at follow up (30-days, 1 year, 3/5/10 years)

    Measured: up to 10 years

  8. Stroke at follow-up

    Stroke at follow up (30-days, 1 year, 3/5/10 years)

    Measured: up to 10 years

  9. Infarct Size

    • hsTnT area under the curve

    Measured: 48 hours from randomization or intervention

  10. Infarct Size

    • Creatine kinase-MB (CK-MB) peak concentration

    Measured: 48 hours from randomization or intervention

  11. Infarct Size

    • CK-MB area under the curve

    Measured: 48 hours from randomization or intervention

  12. Time from randomization to antithrombotic therapy

    Time from randomization to antithrombotic therapy (expressed in minutes)

    Measured: periprocedural

  13. Time from randomization to coronary angiography

    Time from randomization to coronary angiography (expressed in minutes) This outcome will be assessed both in all patients and in patients with OMI according to the different definitions.

    Measured: periprocedural

  14. Angiographic outcomes (restricted to patients undergoing PCI)

    • Worst TIMI flow grade post-PCI (0-3)
    • Worst TIMI thrombus grade post-PCI (0-5)

    Measured: Periprocedural

  15. Total time spent in the emergency department post-randomization

    Total time spent in the emergency department post-randomization

    Measured: periprocedural

  16. Length of hospital stay post-randomization

    Length of hospital stay post-randomization (days)

    Measured: up to 30 days

  17. Resource utilization

    Number of diagnostic tests and procedures performed post-randomization before coronary angiography, including troponin measurements, transthoracic echocardiography and stress testing

    Measured: periprocedural

  18. Health economic outcomes

    These include both direct and indirect costs.

    Direct costs are defined as medical costs incurred post-randomization during the index hospitalization or emergency department visit, including diagnostics and procedures (e.g., ECG, troponin testing, coronary angiography, PCI), medications and consumables, staff time, and length of stay.

    Indirect costs, defined as non-medical or societal costs up to 30 days post-randomization, including lost productivity (e.g., time off work for patients or caregivers), transportation to follow-up visits, informal caregiving support, and early rehabilitation services

    Measured: 30 days

  19. Safety (Serious adverse events)

    Measured: up to 10 years

  20. Diagnostic accuracy of AI algorithm

    Restricted to patients in the control group:

    • Sensitivity
    • Specificity
    • Positive predictive value (PPV)
    • Negative predictive value (NPV)

    Measured: periprocedural

  21. Quality of life (EuroQol 5-Dimension 5-Level [EQ-5D-5L] Index Score)

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument at discharge and 30 days post-randomization. The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses are converted into a single index score using a country-specific value set. The index score typically ranges from values below 0 (worse than death) to 1 (full health), with higher scores indicating better health-related quality of life.

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start23 Aug 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077057
Sponsor's protocol ID
2024-01655
Acronym
TITAN-OMI
Status last verified
Jul 2025
First submitted
1 Jul 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing AI-assisted ECG interpretation (PMcardio) in people with Myocardial Infarction (MI) and Acute Coronary Syndrome (ACS), run by Cardiocentro Ticino at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical primary endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07077057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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