Acute Coronary Syndrome Clinical Trial
Official title:
EKG Criteria and Identification of Acute Coronary Occlusion
NCT number | NCT03863327 |
Other study ID # | 1173733-2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | June 2019 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Stony Brook University Hospital | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Stony Brook University | Hennepin County Medical Center, Minneapolis |
United States,
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
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 |
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