Prognostic Indicators as Provided by the EPIC ClearView

Hypertension Clinical Trial

— GBMC  

Official title:

Prognostic Indicators as Provided by the EPIC ClearView

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476995
• Other study ID #: GBMC Triage Study
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: November 18, 2011
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Epic Research & Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Alcoholic Hepatitis
• Asthma
• Atrial Fibrillation
• Bronchitis
• Celiac Sprue
• Cholecystitis
• Cirrhosis
• Colitis, Ulcerative
• Congestive Heart Failure
• COPD
• Coronary Artery Disease
• Coronary Disease
• Crohn Disease
• Crohn's Disease
• Diabetes
• Diverticulitis
• Emphysema
• Fatty Liver
• Heart Failure
• Heart Valve Diseases
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Hypertension
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome
• Malabsorption Disorders
• Malabsorption Syndromes
• Myocardial Ischemia
• Pancreatitis
• Peptic Ulcer
• Peptic Ulcer Disease
• Pneumonia
• Pyelonephritis
• Renal Failure
• Renal Insufficiency
• Steatohepatitis
• Ulcerative Colitis
• Valvular Heart Disease
• Viral Hepatitis

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Cente	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Epic Research & Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	No
Secondary	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.	Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.	No

External Links

•   EPIC Research and Diagnostics, Inc. Home Page