Clinical trial NCT02287766: Metabolic Syndrome Feasibility Study
Official title: Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 193
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women ages 21-85 who present to the investigators clinical office and meet all of the inclusion criteria while having none of the exclusion criteria will be approached for consent to participate in the study.

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 trends consistent with Metabolic Syndrome identified by medical doctors.


Eligibility criteria: Metabolic Group

Inclusion Criteria:

1. Sex: Male or Female
2. Age range: 21 to 85
3. Qualifying Metabolic Syndrome diagnosis(using the National Cholesterol Education Program Adult Treatment Panel (ATP) III definition)(Grundy, 2004)

   Subjects will be identified as having Metabolic Syndrome if they meet at least three of the following five criteria:
   * Elevated waist circumference: ≥ 102 cm (≥40 inches) in men, ≥ 88 cm (≥35 inches) in women
   * Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides (examples include, but are not limited to, fibrates and nicotinic acid)
   * Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in men or \< 50 mg/dL (1.3 mmol/L) in women or on drug treatment for reduced HDL-C
   * Elevated blood pressure: ≥ 130 mm Hg systolic blood pressure or ≥85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
   * Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated glucose
4. The patient or legal representative is able to understand and provide signed consent for the procedure.

Exclusion Criteria:

1. Patients \< 21years in age or \> 85 years in age.
2. Inability or unwillingness to provide informed consent.
3. Patients with pacemakers or another electrical device implanted somewhere in their body.
4. Pregnant women.
5. Missing all or part of fingers or cuts/burns on pads of fingers
6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging

Control Group:

Inclusion Criteria:

1. Sex: Male or Female
2. Age range: 21 to 85
3. Freedom from qualifying medical diagnoses (control group)

Any one of the following will exclude the subject from participation in the study

1. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
2. Documented current diagnosis/treatment of coronary artery disease or heart attack
3. Documented as currently in Renal Failure (chronic or acute) or on renal dialysis
4. Documented current diagnosis/treatment for Hepatitis

5 .The patient or legal representative is able to understand and provide signed consent for the procedure.

Exclusion Criteria:

1. Patients \< 21 years in age or \> 85 years in age.
2. bility or unwillingness to provide informed consent.
3. Patients with pacemakers or another electrical device implanted somewhere in their body.
4. Pregnant women.
5. Missing all or part of fingers or cuts/burns on pads of fingers
6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging

Primary outcomes:
measure: Agreement of ClearView Scan versus Active Diagnosis
timeFrame: 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:
measure: Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
timeFrame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: EPIC Research and Diagnostics
state: Arizona
city: Scottsdale
country: United States
facility: Integrated Health Institute, LLC
state: Arizona
Study officials:
affiliation: EPIC Research and Diagnostics
name: Nancy R Rizzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: