Prognostic Indicators as Provided by the EPIC ClearView

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Congestive Heart Failure Valvular Heart Disease Atrial Fibrillation Hypertension Pyelonephritis Acute Renal Failure Renal Failure Viral Hepatitis Alcoholic Hepatitis Steatohepatitis Cirrhosis Asthma COPD Bronchitis Emphysema Pneumonia Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Diverticulitis Peptic Ulcer Disease Irritable Bowel Syndrome Cholecystitis Pancreatitis Malabsorption Disorders Celiac Sprue Diabetes

Keywords

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Cardiovascular system gastrointestinal system kidneys liver lungs

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clair A Francomano, MD

Role: PRINCIPAL_INVESTIGATOR

Greater Baltimore Medical Center

Locations

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Greater Baltimore Medical Cente

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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GBMC Triage Study

Identifier Type: -

Identifier Source: org_study_id