Evaluation of Patients in Chest Pain in the Emergency Room

NCT01476982 | Unknown

• 1 other identifier: EPIC-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Cardiac Ischemia

Outcome Measures

Primary Outcomes (1)

• 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.)

Study Arms (1)

Emergency Department Patients

Patients presenting to the Emergency Department complaining of chest pain.

Device: ClearView Scan

Interventions

ClearView Scan DEVICE

Assessment with ClearView device

Emergency Department Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Epic Research & Diagnostics, Inc.: lead
• Scottsdale Healthcare: collaborator

Study Sites (2)

Scottsdale Healthcare Osborn Campus

Scottsdale, Arizona, 85251, United States

Location

Scottsdale Healthcare Shea Campus

Scottsdale, Arizona, 85260, United States

Location

Related Links

• EPIC Research and Diagnostics, Inc.

Study Officials

• Krishnaswami Vijayaraghavan, MD

  Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 22, 2011
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (2)