Evaluation of Patients in Chest Pain in the Emergency Room

NCT ID: NCT01476982

Last Updated: 2013-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Brief Summary

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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 EPICâ„¢ 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.

Detailed Description

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Conditions

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Acute Cardiac Ischemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Emergency Department Patients

Patients presenting to the Emergency Department complaining of chest pain.

ClearView Scan

Intervention Type DEVICE

Assessment with ClearView device

Interventions

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ClearView Scan

Assessment with ClearView device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scottsdale Healthcare

OTHER

Sponsor Role collaborator

Epic Research & Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krishnaswami Vijayaraghavan, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Healthcare

Locations

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Scottsdale Healthcare Osborn Campus

Scottsdale, Arizona, United States

Site Status

Scottsdale Healthcare Shea Campus

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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http://www.epicdiagnostics.com

EPIC Research and Diagnostics, Inc.

Other Identifiers

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EPIC-001

Identifier Type: -

Identifier Source: org_study_id

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