EKG Criteria and Identification of Acute Coronary Occlusion

NCT03863327 | Unknown

• 1 other identifier: 1173733-2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart). The primary analysis will be designed as a multi-center, retrospective case-control study.

Conditions

Acute Coronary Syndrome; STEMI; STEMI - ST Elevation Myocardial Infarction; Acute Coronary Artery Thrombosis (Diagnosis); NSTEMI - Non-ST Segment Elevation MI; Non-ST Elevation Myocardial Infarction; Non ST Segment Elevation Myocardial Infarction; Non ST Segment Elevation Acute Coronary Syndrome; Non-ST Elevation Myocardial Infarction (nSTEMI); Non STEMI

Keywords

Acute Coronary Occlusion; ACO; Occlusive Myocardial Infarction; OMI; Non-occlusive Myocardial Infarction; NOMI

Outcome Measures

Primary Outcomes (1)

• The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction

  How long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria

  1 year

Secondary Outcomes (3)

• The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria

  1 year

• The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients

  1 year

• The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in patients with widened QRS

  1 year

Other Outcomes (9)

• Expert accuracy (sens/spec) for acute triple vessel / left main disease acute coronary syndrome (ACS) as evidenced by global depressions with aVR elevations, other ECG changes.

  1 year

• Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.

  1 year

• The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG

  1 year

Study Arms (4)

Acute Coronary Occlusion or near-occlusion (TIMI 0-1)

a. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-1 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI \> 10 ng/mL or cTnT \> 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis.

Other: No intervention

Acute Coronary Occlusion or near-occlusion (TIMI 0-2)

a. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-2 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI \> 10 ng/mL or cTnT \> 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis.

Other: No intervention

Acute severe 3-vessel disease or critical left main stenosis

1. Severe 3-vessel disease: \>/=75% stenosis in all three major coronary vessels (or equivalents in the case of anatomic variants or preexisting bypass) with an acute culprit lesion (TIMI\<3) or 2. Left main stenosis \> 50% (see Smith review paper for reference): acute left main culprit of any TIMI score, or any lesion of the left main with TIMI\<3 or 3. Any other cardiac catheterization findings prompting initiation of emergent coronary artery bypass grafting within the next 120 hours

Other: No intervention

No evidence of acute coronary occlusion

1. At least three sequential negative cardiac biomarkers within 24 hours of presentation 2. cardiac catheterization showing no culprit lesion. 3. Angiogram showing an acute culprit lesion but both no occlusion (TIMI 2 or greater) and troponins not exceeding the cutoff above 4. If positive troponin values present but no angiography, then the patient must have echocardiography showing no wall motion abnormality and troponin values less than the above cutoff 5. If the patient has insufficient data to classify into one of these categories, the patient must be excluded from the study as they cannot be classified as ACO or non-ACO. For example, patients with extremely high troponin but no culprit seen on cath may have acute occlusion with complete autolysis of thrombus, myocarditis, spasm, etc. Thus the investigators cannot classify them as NO ACO when the possibility of ACO remains and cannot be disproven.

Other: No intervention

Interventions

No intervention OTHER

There will be no intervention as a part of this protocol.

Acute Coronary Occlusion or near-occlusion (TIMI 0-1); Acute Coronary Occlusion or near-occlusion (TIMI 0-2); Acute severe 3-vessel disease or critical left main stenosis; No evidence of acute coronary occlusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to review and include all individuals that underwent urgent or emergent cardiac catheterization over the course of one year (January 1, 2017 - December 31, 2017).

You may qualify if:

• Recorded EKG prior to cardiac catheterization

You may not qualify if:

• Absence of documented EKG prior to cardiac catheterization

Sponsors & Collaborators

• Stony Brook University: lead
• Hennepin County Medical Center, Minneapolis: collaborator

Study Sites (2)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (5)

• Dawkins K, Busk M, Sorensen J, Mortensen LS, Maynard C, Stinnett SS, Wagner GS, Andersen HR; DANAMI-2 investigators. Association between ST segment Resolution following Fibrinolytic therapy or Intracoronary stenting, and Reinfarction in the same myocardial region in the DANAMI-2 study population. Cardiovasc Revasc Med. 2011 Mar-Apr;12(2):75-81. doi: 10.1016/j.carrev.2010.04.003. Epub 2010 Oct 20.

  PMID: 21421184 RESULT

• O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.

  PMID: 23256914 RESULT

• Jaffe AS. Third universal definition of myocardial infarction. Clin Biochem. 2013 Jan;46(1-2):1-4. doi: 10.1016/j.clinbiochem.2012.10.036. Epub 2012 Nov 2. No abstract available.

  PMID: 23127386 RESULT

• Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95. doi: 10.1016/j.jacc.2007.09.011. No abstract available.

  PMID: 18036459 RESULT

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Disease; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen W Smith, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey P Meyers, MD

CONTACT

631-793-2148; harvey.meyers@stonybrookmedicine.edu

Alexander Bracey, MD

CONTACT

631-358-6225; alexander.bracey@stonybrookmedicine.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: May 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

US (2)