Coronary Artery DiseaseGBMCNCT01476995
Prognostic Indicators as Provided by the EPIC ClearView
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by Epic Research & Diagnostics, Inc. at 1 site in United States.
Trial summary
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant, and cannot be undergoing cancer therapy of any kind.
Who may be able to join
- Five Diagnosis Group:
- Sex: Male or Female
- Age range: 18 to 85
- Qualifying medical diagnoses (5 diagnosis groups)
- For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension
Show all 24Show fewer
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (Type 1 and Type 2)
- 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. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
- Control Group:
- Sex: Male or Female
- Age range: 18 to 85
- Freedom from qualifying medical diagnoses (control group)
- For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (type 1 and type 2)
- 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. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
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 implanted somewhere in their body.
- Pregnant women.
- Patients currently undergoing therapy for cancer of any kind.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greater Baltimore Medical Cente
Baltimore, Maryland, 21204
About this study
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation, Hypertension, Pyelonephritis
- Keywords
- Cardiovascular system, gastrointestinal system, kidneys, liver, lungs
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Heart Valve Diseases, Atrial Fibrillation, Hypertension, Pyelonephritis, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Men and women ages 18-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. | |
| Five Diagnosis Group | Men and women ages 18-85 with at least one active medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of ClearView Scan versus Active Diagnosis
Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the physician's diagnoses recorded within the medical record, on a per-subject basis.
Measured: At time of ClearView 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 (1)
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Sensitivity and Specificity of the ClearView Scan relative to an active diagnosis, as the proportion of subjects with correctly captured findings amongst those with an active diagnosis and the proportion of subjects without a ClearView finding amongst those without an active diagnosis, respectively.
Measured: 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 startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epic Research & Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clair A Francomano, MD, Principal investigator, Greater Baltimore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476995
- Sponsor's protocol ID
- GBMC Triage Study
- Acronym
- GBMC
- Status last verified
- Nov 2011
- First submitted
- 3 Oct 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indicators as Provided by the EPIC ClearView
- ClinicalTrials.gov ID
- NCT01476995
- Acronym / sponsor ID
- GBMC / GBMC Triage Study
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation, Hypertension, Pyelonephritis
- Keywords
- Cardiovascular system, gastrointestinal system, kidneys, liver, lungs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Epic Research & Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- 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 objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Men and women ages 18-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. |
| Five Diagnosis Group | – | –Men and women ages 18-85 with at least one active medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant, and cannot be undergoing cancer therapy of any kind.
Key inclusion criteria (24 listed)
- Sex: Male or Female
- Age range: 18 to 85
- Qualifying medical diagnoses (5 diagnosis groups)
- 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. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Key exclusion criteria (5 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 implanted somewhere in their body.
- Pregnant women.
- Patients currently undergoing therapy for cancer of any kind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of ClearView Scan versus Active Diagnosis
Time frame: At time of ClearView 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 physician's diagnoses recorded within the medical record, on a per-subject basis.
1 secondary outcome
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Time frame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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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.
Clair A Francomano, MD principal investigator
Greater Baltimore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by Epic Research & Diagnostics, Inc. at 1 site 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 24 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Diagnosis (time frame: At time of ClearView 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 22 Nov 2011.