Status:
COMPLETED
Prognostic Indicators as Provided by the EPIC ClearView
Lead Sponsor:
Epic Research & Diagnostics, Inc.
Conditions:
Coronary Artery Disease
Congestive Heart Failure
Eligibility:
All Genders
18-85 years
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT01476995
Start Date
September 1 2010
End Date
June 1 2011
Last Update
November 22 2011
Active Locations (1)
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1
Greater Baltimore Medical Cente
Baltimore, Maryland, United States, 21204