Evaluation of Patients in Chest Pain in the Emergency Room (EPIC-ER)
| Tracking Information | |||||
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| First Received Date ICMJE | October 28, 2011 | ||||
| Last Updated Date | March 18, 2013 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Agreement of ClearView scan versus Active (Presenting) Diagnosis [ Time Frame: At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.) ] [ Designated as safety issue: No ] Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the presenting diagnosis/diagnoses for the Emergency Department admission recorded within the medical record, on a per-subject basis. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01476982 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Patients in Chest Pain in the Emergency Room | ||||
| Official Title ICMJE | Evaluation of Patients in Chest Pain in the Emergency Room | ||||
| Brief Summary | The primary objective of this feasibility study is to determine whether it is possible to conduct a study of the ClearView scan among patients under evaluation for acute cardiovascular events, as well as give insight into the performance of the ClearView scoring algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic tool that may assist the health care provider in rapid assessment of the systemic origin of the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource that may benefit an emergency department (ED) by offering expedited "chest pain" etiologic differentiation capabilities. The subsequent results have the potential to include more rapid "chest pain" patient diagnosis and appropriate disposition of non-cardiac chest pain (rule out MI); optimized precious resource expenditure (nursing, physician, inpatient or observation bed, etc.); lower costs to facility, patient and insurance company; and greater patient satisfaction rates due to decreased ED wait time. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Men and women, ages 18-85, presenting to the Emergency Department with chest pain. |
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| Condition ICMJE | Acute Cardiac Ischemia | ||||
| Intervention ICMJE | Device: ClearView Scan
Assessment with ClearView device |
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| Study Group/Cohort (s) | Emergency Department Patients
Patients presenting to the Emergency Department complaining of chest pain.
Intervention: Device: ClearView Scan |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01476982 | ||||
| Other Study ID Numbers ICMJE | EPIC-001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Epic Research & Diagnostics, Inc. | ||||
| Study Sponsor ICMJE | Epic Research & Diagnostics, Inc. | ||||
| Collaborators ICMJE | Scottsdale Healthcare | ||||
| Investigators ICMJE |
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| Information Provided By | Epic Research & Diagnostics, Inc. | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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