Multiple Sclerosis Clinical Trial

Metabolic Syndrome Feasibility Study

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.

View Eligibility Criteria

Eligibility Criteria

Metabolic Group

Inclusion Criteria:

Sex: Male or Female
Age range: 21 to 85

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

Exclusion Criteria:

Patients < 21years 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.
Missing all or part of fingers or cuts/burns on pads of fingers
Hand tremors or involuntary oscillations of the hands that prevents clear imaging

Control Group:

Inclusion Criteria:

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

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

Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
Documented current diagnosis/treatment of coronary artery disease or heart attack
Documented as currently in Renal Failure (chronic or acute) or on renal dialysis
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:

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

193

Study ID:

NCT02287766

Recruitment Status:

Completed

Sponsor:

Epic Research & Diagnostics, Inc.

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There is 1 Location for this study

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EPIC Research and Diagnostics
Scottsdale Arizona, 85255, United States
Integrated Health Institute, LLC
Scottsdale Arizona, 85255, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

193

Study ID:

NCT02287766

Recruitment Status:

Completed

Sponsor:


Epic Research & Diagnostics, Inc.

How clear is this clinincal trial information?

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