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
  Purpose

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.


Condition Intervention
Acute Cardiac Ischemia
Device: ClearView Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Patients in Chest Pain in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Epic Research & Diagnostics, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Emergency Department Patients
Patients presenting to the Emergency Department complaining of chest pain.
Device: ClearView Scan
Assessment with ClearView device

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476982

Locations
United States, Arizona
Scottsdale Healthcare Shea Campus
Scottsdale, Arizona, United States, 85260
Scottsdale Healthcare Osborn Campus
Scottsdale, Arizona, United States, 85251
Sponsors and Collaborators
Epic Research & Diagnostics, Inc.
Scottsdale Healthcare
Investigators
Principal Investigator: Krishnaswami Vijayaraghavan, MD Scottsdale Healthcare
  More Information

Additional Information:
No publications provided

Responsible Party: Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01476982     History of Changes
Other Study ID Numbers: EPIC-001
Study First Received: October 28, 2011
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Emergencies
Ischemia
Pain
Signs and Symptoms
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014