Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI

NCT06570759 | Active Not Recruiting DMC

• 1 other identifier: BC&SSH-002
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 18

Brief Summary

The investigators hypothesize that occlusion myocardial infarction(MI)/non-occlusion MI approach to MI treatment will better predict acute coronary occlusion on coronary angiography, better limit infarct size, better preserve left ventricular function and result in lower long-term adverse cardiac events (all cause mortality, all cause rehospitalization) compared to standard ST-elevation/non-ST-elevation MI paradigm.

Conditions

Myocardial Infarction; Myocardial Ischemia; Acute Coronary Syndrome; Diagnosis; Morality

Outcome Measures

Primary Outcomes (2)

• Primary end point: Major adverse events (Mortality and rehospitalization)

  The difference in the combined rate of all-cause mortality, all-cause

  One year

• Primary end point: Major adverse events (Mortality and rehospitalization) in STEMI (-) OMI (+) subgroup

  The dual-primary endpoint is all-cause mortality and all-cause re-hospitalization in OMI (+) STEMI (-) patient subgroups.

  One year

Secondary Outcomes (2)

• Secondary end point: Diagnosis of acute coronary occlusion

  One week

• Secondary end point: Short-term major cardiovascular events

  One month

Other Outcomes (2)

• Secondary end point: Infarct size by biomarkers

  72 hours

• Secondary end point: Infarct size by echocardiography

  One week

Study Arms (2)

OMI/NOMI arm

EXPERIMENTAL

Any clinical or ECG evidence of acute total or near-total coronary occlusion will be intervened immediately. Other patients will be managed as standard NSTEMI guidelines.

Procedure: Early intervention for OMI; Procedure: Standard early intervention for STEMI; Procedure: Standard delayed intervention for NSTEMI

STEMI/NSTEMI arm

ACTIVE COMPARATOR

The patients fulfilling STEMI ECG criteria will be intervened immediately. Other patients will be managed as standard NSTEMI guidelines.

Procedure: Standard early intervention for STEMI; Procedure: Standard delayed intervention for NSTEMI

Interventions

Early intervention for OMI PROCEDURE

Early PCI for OMI (+) STEMI (-) patients

OMI/NOMI arm

Standard early intervention for STEMI PROCEDURE

Early PCI for OMI (+) and STEMI (+) patients

OMI/NOMI arm; STEMI/NSTEMI arm

Standard delayed intervention for NSTEMI PROCEDURE

Medical stabilization and then PCI for OMI (-) and STEMI (-) patients

OMI/NOMI arm; STEMI/NSTEMI arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• ECG and/or clinical diagnosis of acute myocardial infarction

You may not qualify if:

• Active pregnancy or a suspicion of pregnancy
• Rejection or withdrawal of consent
• Failure to acquire any of the pre-participation ECGs
• Non-ischemic myocardial injury
• Application of thrombolytic therapy instead of primary PCI
• Re-occlusion of the culprit lesion after intervention\*
• New vessel occlusion during hospital stay\*

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Ankara Etlik City Hospital: collaborator
• Antalya City Hospital: collaborator
• Bağcılar Training and Research Hospital: collaborator
• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: collaborator
• Ataturk University: collaborator
• Eskisehir City Hospital: collaborator
• Kartal Kosuyolu High Speciality Training and Research Hospital: collaborator
• Marmara University Pendik Training and Research Hospital: collaborator
• Istanbul Mehmet Akif Ersoy Educational and Training Hospital: collaborator
• Muğla Sıtkı Koçman University: collaborator
• Necmettin Erbakan University: collaborator
• Eskisehir Osmangazi University: collaborator
• Sirnak State Hospital: collaborator
• Tokat Gaziosmanpasa University: collaborator
• Van Training and Research Hospital: collaborator
• Yuzuncu Yil University: collaborator
• Kutahya Health Sciences University: collaborator

Study Sites (18)

Ankara Etlik City Hospital

Ankara, 6010, Turkey (Türkiye)

Location

Antalya City Hospital

Antalya, 07080, Turkey (Türkiye)

Location

Erzurum Atatürk University Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Hospital

Eskişehir, 26040, Turkey (Türkiye)

Location

Eskişehir City Hospital

Eskişehir, 26080, Turkey (Türkiye)

Location

Mehmet Akif Ersoy Cardiovascular and Throacic Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Basaksehir Cam and Sakura City Hospital

Istanbul, 3440, Turkey (Türkiye)

Location

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Kartal Kosuyolu Training and Research Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

Marmara University, Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

Bağcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Necmettin Erbakan Meram Tıp Fakültesi Hastanesi

Konya, 42080, Turkey (Türkiye)

Location

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

Location

Sirnak State Hospital

Şırnak, 73000, Turkey (Türkiye)

Location

Tokat Gaziosmanpaşa University

Tokat Province, 60030, Turkey (Türkiye)

Location

Yuzuncu Yil University Hospital

Van, 65080, Turkey (Türkiye)

Location

Van Training and Research Hospital

Van, 65300, Turkey (Türkiye)

Location

Related Publications (8)

• Herman R, Meyers HP, Smith SW, Bertolone DT, Leone A, Bermpeis K, Viscusi MM, Belmonte M, Demolder A, Boza V, Vavrik B, Kresnakova V, Iring A, Martonak M, Bahyl J, Kisova T, Schelfaut D, Vanderheyden M, Perl L, Aslanger EK, Hatala R, Wojakowski W, Bartunek J, Barbato E. International evaluation of an artificial intelligence-powered electrocardiogram model detecting acute coronary occlusion myocardial infarction. Eur Heart J Digit Health. 2023 Nov 28;5(2):123-133. doi: 10.1093/ehjdh/ztad074. eCollection 2024 Mar.

  PMID: 38505483 BACKGROUND

• Aslanger EK. Beyond the ST-segment in Occlusion Myocardial Infarction (OMI): Diagnosing the OMI-nous. Turk J Emerg Med. 2022 Sep 28;23(1):1-4. doi: 10.4103/2452-2473.357333. eCollection 2023 Jan-Mar.

  PMID: 36818946 BACKGROUND

• Aslanger EK, Meyers HP, Smith SW. Recognizing electrocardiographically subtle occlusion myocardial infarction and differentiating it from mimics: Ten steps to or away from cath lab. Turk Kardiyol Dern Ars. 2021 Sep;49(6):488-500. doi: 10.5543/tkda.2021.21026.

  PMID: 34523597 BACKGROUND

• Aslanger EK, Meyers HP, Smith SW. Time for a new paradigm shift in myocardial infarction. Anatol J Cardiol. 2021 Mar;25(3):156-162. doi: 10.5152/AnatolJCardiol.2021.89304.

  PMID: 33690129 BACKGROUND

• Aslanger EK, Meyers PH, Smith SW. STEMI: A transitional fossil in MI classification? J Electrocardiol. 2021 Mar-Apr;65:163-169. doi: 10.1016/j.jelectrocard.2021.02.001. Epub 2021 Feb 13.

  PMID: 33640636 BACKGROUND

• Aslanger EK, Meyers HP, Bracey A, Smith SW. The STEMI/NonSTEMI Dichotomy needs to be replaced by Occlusion MI vs. Non-Occlusion MI. Int J Cardiol. 2021 May 1;330:15. doi: 10.1016/j.ijcard.2021.02.015. Epub 2021 Feb 10. No abstract available.

  PMID: 33577907 BACKGROUND

• Aslanger EK, Yildirimturk O, Simsek B, Bozbeyoglu E, Simsek MA, Yucel Karabay C, Smith SW, Degertekin M. DIagnostic accuracy oF electrocardiogram for acute coronary OCClUsion resuLTing in myocardial infarction (DIFOCCULT Study). Int J Cardiol Heart Vasc. 2020 Jul 30;30:100603. doi: 10.1016/j.ijcha.2020.100603. eCollection 2020 Oct.

  PMID: 32775606 BACKGROUND

• Aslanger EK, Aggul B, Yildirimturk O, Karabay CY, Meyers HP, Smith SW, Degertekin M; DIFOCCULT-3 Study Investigators; Steering Committee; Expert ECG Board; Investigators; Data Monitoring Board; Safety Monitoring and Outcome Adjudication Board. A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial. JACC Adv. 2025 Nov;4(11 Pt 2):102227. doi: 10.1016/j.jacadv.2025.102227. Epub 2025 Oct 22.

  PMID: 41128712 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia; Acute Coronary Syndrome; Disease

Interventions

Early Intervention, Educational; High-Temperature Requirement A Serine Peptidase 2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Apoptosis Regulatory Proteins; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Mitochondrial Proteins; Parkinson Disease Associated Proteins

Study Officials

• Emre K Aslanger, Prof

  Basaksehir Pine and Sakura City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The patients will be randomized to the current STEMI/NSTEMI versus OMI/NOMI approaches using a cluster randomized trial design. In each center, a STEMI/NSTEMI and an OMI/NOMI intervention group will be formed from intervenional cardiologists. After these two groups are formed, the patients will be block-randomized into STEMI/NSTEMI and OMI/NOMI cohorts according to the team on-duty, i.e., the approach that center will follow on a certain day will be defined by the team on duty. The interventional cardiologists in both groups will be ensured to have a similar experience level (in terms of years of training, and angiography and primary PCI counts in the past year). When an OMI/NOMI investigator is on duty, AI supported ECG application will interpret ECGs as OMI or not-OMI. When a STEMI/STEMI investigator is on duty, AI supported ECG application will not interpret the ECG and will prompt "Follow standard care".

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-03

Locations

TU (18)