EKG Criteria and Identification of Acute Coronary Occlusion

Acute Coronary Syndrome Clinical Trial

Official title:

EKG Criteria and Identification of Acute Coronary Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863327
• Other study ID #: 1173733-2
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: June 2019

Study information

• Verified date: March 2019
• Source: Stony Brook University
• Contact: Harvey P Meyers, MD
• Phone: 631-793-2148
• Email: harvey.meyers[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Recorded EKG prior to cardiac catheterization

Exclusion Criteria:

• Absence of documented EKG prior to cardiac catheterization

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention
There will be no intervention as a part of this protocol.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

References & 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 myocardia — View 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. — View 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. — View 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, — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Explore the rate of false positive cath lab activations	Explore the rate of false positive cath lab activations	1 year
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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