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EKG Criteria and Identification of Acute Coronary Occlusion

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ClinicalTrials.gov Identifier: NCT03863327
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
Stony Brook University

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.


Condition or disease Intervention/treatment
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 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: EKG Criteria and Identification of Acute Coronary Occlusion
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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

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




Primary Outcome Measures :
  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 [ Time Frame: 1 year ]
    How long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria


Secondary Outcome Measures :
  1. The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria [ Time Frame: 1 year ]
    The difference in sensitivity among the occlusive myocardial infarction cohort for experts versus STEMI criteria

  2. The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients [ Time Frame: 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

  3. 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 [ Time Frame: 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


Other Outcome Measures:
  1. 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. [ Time Frame: 1 year ]
    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.

  2. Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications. [ Time Frame: 1 year ]
    Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.

  3. The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG [ Time Frame: 1 year ]
    The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG

  4. Explore the rate of false positive cath lab activations [ Time Frame: 1 year ]
    Explore the rate of false positive cath lab activations

  5. Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria [ Time Frame: 1 year ]
    Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria

  6. Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria [ Time Frame: 1 year ]
    Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria

  7. Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria. [ Time Frame: 1 year ]
    Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.

  8. Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria [ Time Frame: 1 year ]
    Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria

  9. Determine the rate of correct expert ECG interpretation of false positive STEMI criteria [ Time Frame: 1 year ]
    Determine the rate of correct expert ECG interpretation of false positive STEMI criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • Recorded EKG prior to cardiac catheterization

Exclusion Criteria:

  • Absence of documented EKG prior to cardiac catheterization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863327


Contacts
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Contact: Harvey P Meyers, MD 631-793-2148 harvey.meyers@stonybrookmedicine.edu
Contact: Alexander Bracey, MD 631-358-6225 alexander.bracey@stonybrookmedicine.edu

Locations
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United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Daniel Lee, MD         
Sub-Investigator: Daniel Lee, MD         
Principal Investigator: Stephen W Smith, MD         
Sub-Investigator: Deborah L Zyosec         
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Harvey P Meyers, MD    631-793-2148    harvey.meyers@stonybrookmedicine.edu   
Contact: Alexander Bracey, MD    631-358-6225    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         
Sponsors and Collaborators
Stony Brook University
Hennepin County Medical Center, Minneapolis
Investigators
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Principal Investigator: Stephen W Smith, MD Hennepin County Medical Center, Minneapolis
Publications of Results:

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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT03863327    
Other Study ID Numbers: 1173733-2
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stony Brook University:
Acute Coronary Occlusion
ACO
Occlusive Myocardial Infarction
OMI
Non-occlusive Myocardial Infarction
NOMI
Additional relevant MeSH terms:
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Myocardial Infarction
Thrombosis
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Coronary Occlusion
Coronary Thrombosis
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Coronary Disease