Clinical trial NCT03863327: EKG Criteria and Identification of Acute Coronary Occlusion
Official title: EKG Criteria and Identification of Acute Coronary Occlusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Hennepin County Medical Center, Minneapolis
First posted: 2019-03-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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.

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.

Eligibility criteria: Inclusion Criteria:

* Recorded EKG prior to cardiac catheterization

Exclusion Criteria:

* Absence of documented EKG prior to cardiac catheterization

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria
timeFrame: 1 year
measure: The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
measure: 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.
timeFrame: 1 year
measure: Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.
timeFrame: 1 year
measure: The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG
timeFrame: 1 year
measure: Explore the rate of false positive cath lab activations
timeFrame: 1 year
measure: Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria
timeFrame: 1 year
measure: Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria
timeFrame: 1 year
measure: Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.
timeFrame: 1 year
measure: Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria
timeFrame: 1 year
measure: Determine the rate of correct expert ECG interpretation of false positive STEMI criteria
timeFrame: 1 year
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Stephen W Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.