Time for a Paradigm Shift: STEMI/NSTEMI to OMI/NOMI ?

NCT05705102 | Terminated

• 1 other identifier: MarmaraCard002
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The current ST-segment elevation (STEMI)/non-STEMI treatment paradigm misses nearly one fourth of acute coronary occlusions (ACO) that needs immediately reperfusion. Many of these cases can be recognized by subtle changes on ECG, but the current STEMI criteria do not include them. The investigators of this research believe a new occlusive/non-occlusive myocardial infarction (OMI/NOMI) approach will be superior to the established STEMI/non-STEMI paradigm in early detection of ACO, limiting infarct size, reducing re-hospitalizations and most important of all, reducing mortality.

Conditions

Myocardial Infarction; Myocardial Ischemia

Keywords

acute coronary occlusion; electrocardiography; myocardial infarction; ST-segment elevation

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality

  One year

• Mortality in OMI (+) but STEMI (-) patients

  Mortality in OMI (+) but STEMI (-) patients

  One year

Secondary Outcomes (3)

• ACO

  At index hospitalization (<7 day)

• Infarct size

  At index hospitalization (<7 day)

• Left ventricular function

  At index hospitalization (<7 day)

Study Arms (2)

OMI/NOMI group

In this group, the patients will be managed according to OMI/NOMI paradigm. OMI patients, even without STEMI criteria, will be taken immediately to the cath lab.

Other: Coronary intervention

STEMI/NSTEMI group

Standard care

Other: Coronary intervention

Interventions

Coronary intervention OTHER

Coronary intervention will be done immediately in patients with OMI (even STEMI criteria are negative), instead of waiting for \<24h.

OMI/NOMI group; STEMI/NSTEMI group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The adult patients who are admitted to the emergency department with a clinical picture compatible with acute coronary syndrome.

You may qualify if:

• Clinical picture compatible with acute coronary syndrome AND recognized as OMI/STEMI (according to the treating provider) or cardiac high-sensitive troponins levels are elevated

You may not qualify if:

• Unable to acquire ECG

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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

• Pendell Meyers H, Bracey A, Lee D, Lichtenheld A, Li WJ, Singer DD, Rollins Z, Kane JA, Dodd KW, Meyers KE, Shroff GR, Singer AJ, Smith SW. Accuracy of OMI ECG findings versus STEMI criteria for diagnosis of acute coronary occlusion myocardial infarction. Int J Cardiol Heart Vasc. 2021 Apr 12;33:100767. doi: 10.1016/j.ijcha.2021.100767. eCollection 2021 Apr.

  PMID: 33912650 BACKGROUND

• Meyers HP, Bracey A, Lee D, Lichtenheld A, Li WJ, Singer DD, Kane JA, Dodd KW, Meyers KE, Thode HC, Shroff GR, Singer AJ, Smith SW. Comparison of the ST-Elevation Myocardial Infarction (STEMI) vs. NSTEMI and Occlusion MI (OMI) vs. NOMI Paradigms of Acute MI. J Emerg Med. 2021 Mar;60(3):273-284. doi: 10.1016/j.jemermed.2020.10.026. Epub 2020 Dec 9.

  PMID: 33308915 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, 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

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Emre Aslanger

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: August 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

TU (1)