NCT02287766已完成不适用
Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView
Epic Research & Diagnostics, Inc.2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2014年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Agreement of ClearView Scan versus Active Diagnosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Agreement of ClearView Scan versus Active Diagnosis
时间窗: 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
The EPIC ClearView software produces a Response Scale report that summarizes the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function.These measurements will then be compared to metabolic diagnosis.
次要结局
- Sensitivity and Specificity of ClearView Scan versus Active Diagnosis(Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit)
研究者
研究点 (2)
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