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EKG Criteria and Identification of Acute Coronary Occlusion

EKG Criteria and Identification of Acute Coronary Occlusion

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03863327
Enrollment
2000
Registered
2019-03-05
Start date
2018-05-01
Completion date
2019-06-30
Last updated
2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERNo intervention

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

Sponsors

Hennepin County Medical Center, Minneapolis
CollaboratorOTHER
Stony Brook University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Recorded EKG prior to cardiac catheterization

Exclusion criteria

* Absence of documented EKG prior to cardiac catheterization

Design outcomes

Primary

MeasureTime frameDescription
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 infarction1 yearHow long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria

Secondary

MeasureTime frameDescription
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients1 yearThe 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 patients with widened QRS1 yearThe 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) criteria1 yearThe difference in sensitivity among the occlusive myocardial infarction cohort for experts versus STEMI criteria

Other

MeasureTime frameDescription
Explore the rate of false positive cath lab activations1 yearExplore the rate of false positive cath lab activations
Explore the rationale for correct expert ECG interpretation of OMI without STEMI criteria1 yearExplore the rationale for correct expert ECG interpretation of OMI without STEMI criteria
Explore the rationale for correct expert ECG interpretation of false positive STEMI criteria1 yearExplore the rationale for correct expert ECG interpretation of false positive STEMI criteria
Time from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.1 yearTime from initial ECG with subtle OMI without STEMI criteria to development of ECG meeting STEMI criteria.
Determine the rate of correct expert ECG interpretation of OMI without STEMI criteria1 yearDetermine the rate of correct expert ECG interpretation of OMI without STEMI criteria
Determine the rate of correct expert ECG interpretation of false positive STEMI criteria1 yearDetermine the rate of correct expert ECG interpretation of false positive STEMI criteria
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 yearExpert 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.
Time difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.1 yearTime difference in the subtle OMI group stratified based on the presence or absence of opioid pain medications.
The rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG1 yearThe rate of patients with ECGs that meet STEMI criteria that then experience a delay despite positive EKG

Countries

United States

Contacts

Primary ContactHarvey P Meyers, MD
harvey.meyers@stonybrookmedicine.edu631-793-2148
Backup ContactAlexander Bracey, MD
alexander.bracey@stonybrookmedicine.edu631-358-6225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026