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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Cardiac Ischemia
• Intervention / Treatment: Device: ClearView Scan

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Scottsdale Healthcare Osborn Campus
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare Shea Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women, ages 18-85, presenting to the Emergency Department with chest pain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of ClearView scan versus Active (Presenting) Diagnosis	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.	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.)

Collaborators and Investigators

• Sponsor: Epic Research & Diagnostics, Inc.
• Collaborators: Scottsdale Healthcare
• Investigators: Principal Investigator: Krishnaswami Vijayaraghavan, MD, Scottsdale Healthcare

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 20, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Disease Attributes; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Emergencies; Ischemia; Chest Pain
• Other Study ID Numbers: EPIC-001