Prognostic Indicators as Provided by the EPIC ClearView (GBMC)

November 18, 2011 updated by: Epic Research & Diagnostics, Inc.
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Cente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Five Diagnosis Group:

  1. Sex: Male or Female
  2. Age range: 18 to 85

  3. 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
    • 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)
  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. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.

Control Group:

  1. Sex: Male or Female
  2. Age range: 18 to 85

  3. 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)
  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. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.

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 implanted somewhere in their body.
  • Pregnant women.
  • Patients currently undergoing therapy for cancer of any kind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epic Research & Diagnostics, Inc.

Investigators

  • Principal Investigator: Clair A Francomano, MD, Greater Baltimore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBMC Triage Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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