Evaluation of Patients in Chest Pain in the Emergency Room (EPIC-ER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476982
Recruitment Status : Unknown
Verified March 2013 by Epic Research & Diagnostics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : March 20, 2013
Scottsdale Healthcare
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.

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.

Condition or disease Intervention/treatment
Acute Cardiac Ischemia Device: ClearView Scan

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Patients in Chest Pain in the Emergency Room
Study Start Date : May 2012
Estimated Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Emergency Department Patients
Patients presenting to the Emergency Department complaining of chest pain.
Device: ClearView Scan
Assessment with ClearView device

Primary Outcome Measures :
  1. 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.) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women, ages 18-85, presenting to the Emergency Department with chest pain.

Inclusion Criteria:

  1. Sex: Male or Female
  2. Age range: 18 to 85
  3. Chief complaint upon admission to the ED: chest pain
  4. The patient or legal representative is able to understand and provide signed consent for the procedure.
  5. Every effort will be given to balance subjects by gender, age, and race.

Exclusion Criteria:

  1. Patients < 18 years in age or > 85 years in age.
  2. Inability or unwillingness to provide informed consent.
  3. Patients with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.
  4. Patients connected to an electrical device that cannot be removed (i.e. monitor).
  5. Pregnant women.
  6. Patients currently undergoing therapy for cancer of any kind.
  7. Patients missing all or part of any of their fingers.
  8. Patients with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476982

United States, Arizona
Scottsdale Healthcare Osborn Campus
Scottsdale, Arizona, United States, 85251
Scottsdale Healthcare Shea Campus
Scottsdale, Arizona, United States, 85260
Sponsors and Collaborators
Epic Research & Diagnostics, Inc.
Scottsdale Healthcare
Principal Investigator: Krishnaswami Vijayaraghavan, MD Scottsdale Healthcare

Additional Information:
Responsible Party: Epic Research & Diagnostics, Inc. Identifier: NCT01476982     History of Changes
Other Study ID Numbers: EPIC-001
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases