Overview

This trial is active, not recruiting.

Condition acute cardiac ischemia
Treatment clearview scan
Sponsor Epic Research & Diagnostics, Inc.
Collaborator Scottsdale Healthcare
Start date May 2012
End date June 2013
Trial size 200 participants
Trial identifier NCT01476982, EPIC-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
Patients presenting to the Emergency Department complaining of chest pain.
clearview scan
Assessment with ClearView device

Primary Outcomes

Measure
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.)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Evaluation of Patients in Chest Pain in the Emergency Room
Principal investigator Krishnaswami Vijayaraghavan, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Epic Research & Diagnostics, Inc..