EKG Criteria and Identification of Acute Coronary Occlusion

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; STEMI; NSTEMI - Non-ST Segment Elevation MI; Non ST Segment Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; STEMI - ST Elevation Myocardial Infarction; Acute Coronary Artery Thrombosis (Diagnosis); Non ST Segment Elevation Acute Coronary Syndrome; Non-ST Elevation Myocardial Infarction (nSTEMI); Non STEMI
• Intervention / Treatment: Other: No intervention

Detailed Description

In this retrospective, 2-center, case-control study the investigators will investigate and compare the accuracy of various ECG criteria and expert interpretation to diagnose Acute Coronary Occlusion (ACO), with an emphasis on the diagnosis of patients with ACO but without obvious ST segment Elevation Myocardial Infarction (STEMI) criteria. The investigators will use two cohorts of patients who present with symptoms consistent with acute MI, one subsequently proven to have ACO and one proven to not have ACO.

The groups will be identified by chart reviewers who will use all clinical data except the ECGs to determine, in retrospect, and using strict criteria, if the patient had ACO at the time of the ECGs to be evaluated, or not. These reviewers will be blinded to all ECGs. The diagnosis of ACO will be dependent upon angiographic occlusion. Because in many cases of ACO, the artery spontaneously opens by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit on the angiogram PLUS a very elevated peak troponin, as peak troponin I > 10.0 ng/mL and peak troponin T > 1.0 ng/mL are highly correlated with ACO.

The investigators will find cases of subtle STEMI (ACO without STEMI criteria) by searching for all myocardial infarction cases that underwent angiography and percutaneous coronary intervention (PCI). The investigators will attempt by various criteria to determine from all available sources other than the ECG (angiography, echo, troponins) whether the involved artery was occluded at the time of the most diagnostic ECG that was recorded while the patient had symptoms and before the angiogram. Reviewers determining ACO or not ACO will be blinded to the ECGs. The investigators will use each pre-angiogram ECG, in sequence, for analysis, to determine if expert interpretation can not only identify occlusion that is not identified by STEMI criteria, but also to find if expert interpretation can identify occlusion on an earlier ECG. Expert ECG interpreters will interpret the ECG for evidence of ACO. Their accuracy will be compared to traditional STEMI criteria and other methods of interpretation if available.

The investigators will use as controls patients with any ST elevation, or ST depression, of any etiology that are proven to NOT have occlusion. The investigators will establish absence of occlusion by a combination of objective data points including angiogram (if performed), troponins, echocardiograms, clinical course, etc. Details of the methods are below, including specific outcome definitions used to claim the presence or absence of ACO.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin County Medical Center
      • Contact: Daniel Lee, MD
      • Sub-Investigator: Daniel Lee, MD
      • Principal Investigator: Stephen W Smith, MD
      • Sub-Investigator: Deborah L Zyosec
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Harvey P Meyers, MD; Phone Number: 631-793-2148; Email: harvey.meyers@stonybrookmedicine.edu
      • Contact: Alexander Bracey, MD; Phone Number: 631-358-6225; Email: alexander.bracey@stonybrookmedicine.edu
      • Principal Investigator: Adam J Singer, MD
      • Sub-Investigator: Harvey P Meyers, MD
      • Sub-Investigator: Alexander Bracey, MD
      • Sub-Investigator: Kristen E Meyers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• Recorded EKG prior to cardiac catheterization

Exclusion Criteria:

• Absence of documented EKG prior to cardiac catheterization

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; There will be no intervention as a part of this protocol.
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; There will be no intervention as a part of this protocol.
Acute severe 3-vessel disease or critical left main stenosis; 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; 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; Any other cardiac catheterization findings prompting initiation of emergent coronary artery bypass grafting within the next 120 hours	Other: No intervention; There will be no intervention as a part of this protocol.
No evidence of acute coronary occlusion; At least three sequential negative cardiac biomarkers within 24 hours of presentation; cardiac catheterization showing no culprit lesion.; Angiogram showing an acute culprit lesion but both no occlusion (TIMI 2 or greater) and troponins not exceeding the cutoff above; 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; 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; There will be no intervention as a part of this protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria	The difference in sensitivity among the occlusive myocardial infarction cohort for experts versus 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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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. Currently, there are no ECG diagnostic criteria for these entities.	1 year
Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.	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	The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG	1 year
Explore the rate of false positive cath lab activations	Explore the rate of false positive cath lab activations	1 year
Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria	Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria	1 year
Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria	Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria	1 year
Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.	Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.	1 year
Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria	Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria	1 year
Determine the rate of correct expert ECG interpretation of false positive STEMI criteria	Determine the rate of correct expert ECG interpretation of false positive STEMI criteria	1 year

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Hennepin County Medical Center, Minneapolis
• Investigators: Principal Investigator: Stephen W Smith, MD, Hennepin County Medical Center, Minneapolis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: NOMI; ACO; Acute Coronary Occlusion; Occlusive Myocardial Infarction; OMI; Non-occlusive Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Coronary Disease; Myocardial Infarction; Infarction; Syndrome; ST Elevation Myocardial Infarction; Thrombosis; Acute Coronary Syndrome; Coronary Occlusion; Non-ST Elevated Myocardial Infarction; Coronary Thrombosis
• Other Study ID Numbers: 1173733-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No