NCT00258973已完成不适用
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Bioequivalency of carotid IMT measurements.
研究概览
简要总结
The purposes of this study are to determine:
- Inter-site variability in CIMT image measurement using SonoCalcTM.
- If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of CIMT and (b) determination of plaque presence.
- If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory.
- If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention.
详细描述
Phase
IV
Type (observational vs. interventional)
Observational
Currently recruiting or not?
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males over 45 years and females over 55 years of age with at least one additional risk factor for coronary artery disease.
- •Females 45-54 years old may be enrolled if they have a family history of CHD (myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden cardiac death) in a male first degree relative <55 or a female first degree relative <65 years old AND at least one additional risk factor for coronary artery disease.
排除标准
- •Age >70 years
- •Subjects taking cholesterol-lowering medications
- •Active liver disease
- •Active thyroid disease
- •Uncontrolled hypertension
- •Chronic kidney disease
- •History of coronary artery disease
- •History of cerebrovascular disease
- •History of peripheral arterial disease
结局指标
主要结局
Bioequivalency of carotid IMT measurements.
次要结局
- Variability in carotid IMT measurements
- Intention to behavior change in patients
- Effects of carotid IMT on physician management
研究者
研究点 (1)
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