Acute Cardiac IschemiaEPIC-ERNCT01476982
Evaluation of Patients in Chest Pain in the Emergency Room
An observational study of Acute Cardiac Ischemia, run by Epic Research & Diagnostics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Cardiac Ischemia
- What is being tested?
- ClearView Scan
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women, ages 18-85, presenting to the Emergency Department with chest pain.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Scottsdale Healthcare Osborn Campus
Scottsdale, Arizona, 85251
Scottsdale Healthcare Shea Campus
Scottsdale, Arizona, 85260
About this study
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
- Being tested
- ClearView Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearView ScanDevice
Assessment with ClearView device
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department Patients | Patients presenting to the Emergency Department complaining of chest pain. Receives: Device: ClearView Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cardiac IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epic Research & Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scottsdale Healthcare
- Responsible party
- Sponsor
- Investigators
- Krishnaswami Vijayaraghavan, MD, Principal investigator, Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476982
- Sponsor's protocol ID
- EPIC-001
- Acronym
- EPIC-ER
- Status last verified
- Mar 2013
- First submitted
- 28 Oct 2011
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients in Chest Pain in the Emergency Room
- ClinicalTrials.gov ID
- NCT01476982
- Acronym / sponsor ID
- EPIC-ER / EPIC-001
- Conditions
- Acute Cardiac Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Epic Research & Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Scottsdale Healthcare
- Study start
- May 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Patients | – | Device: ClearView ScanPatients presenting to the Emergency Department complaining of chest pain. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, ages 18-85, presenting to the Emergency Department with chest pain.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearView ScanAssessment with ClearView device | Device | Emergency Department Patients |
Primary outcome
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.)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishnaswami Vijayaraghavan, MD principal investigator
Scottsdale Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiac Ischemia, run by Epic Research & Diagnostics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.