Clinical trial NCT01476982: Evaluation of Patients in Chest Pain in the Emergency Room
Official title: Evaluation of Patients in Chest Pain in the Emergency Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Cardiac Ischemia
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Scottsdale Healthcare
First posted: 2011-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women, ages 18-85, presenting to the Emergency Department with chest pain.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Agreement of ClearView scan versus Active (Presenting) Diagnosis
timeFrame: 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.)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Osborn Campus
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Shea Campus
state: Arizona
Study officials:
affiliation: Scottsdale Healthcare
name: Krishnaswami Vijayaraghavan, MD
role: PRINCIPAL_INVESTIGATOR
References: