Evaluation of Patients in Chest Pain in the Emergency Room | NCT01476982

Studies
Evaluation of Patients in Chest Pain in the Emergency Room

NCT01476982

Sponsor

Epic Research & Diagnostics, Inc.

Status

Unknown status

Last Update Posted

Mar 20, 2013Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute Cardiac Ischemia

Interventions

ClearView Scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jun 2013Estimated

Completion Date

Not provided

First Submitted Date

Oct 28, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2013

Last Update Posted Date

Mar 20, 2013Estimated

Name	Class
Scottsdale Healthcare	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Emergency Department Patients		Patients presenting to the Emergency Department complaining of chest pain.	Device: ClearView Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ClearView Scan	Device	Assessment with ClearView device	Emergency Department Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krishnaswami Vijayaraghavan, MD	Scottsdale Healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scottsdale Healthcare Osborn Campus		Scottsdale	Arizona	85251	United States
Scottsdale Healthcare Shea Campus