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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Scottsdale Healthcare
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01476982
First received: October 28, 2011
Last updated: March 18, 2013
Last verified: March 2013

October 28, 2011
March 18, 2013
May 2012
June 2013   (final data collection date for primary outcome 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.) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01476982 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluation of Patients in Chest Pain in the Emergency Room
Evaluation of Patients in Chest Pain in the Emergency Room

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

Acute Cardiac Ischemia
Device: ClearView Scan
Assessment with ClearView device
Emergency Department Patients
Patients presenting to the Emergency Department complaining of chest pain.
Intervention: Device: ClearView Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01476982
EPIC-001
No
Epic Research & Diagnostics, Inc.
Epic Research & Diagnostics, Inc.
Scottsdale Healthcare
Principal Investigator: Krishnaswami Vijayaraghavan, MD Scottsdale Healthcare
Epic Research & Diagnostics, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP