A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors in Asymptomatic Nationwide Indian Population (SCORE India)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
研究概览
简要总结
This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain the distribution of measurements of CIMT in Indian subjects and will involve approx. 30 investigative sites from all over the country. Each investigative site will be expected to enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each individual as described in the protocol.
All the procedures could be completed in a single day, however due to any reason any study variable is not taken subject may be asked to come back for a second visit within 7 days of the first visit.
详细描述
A Study to derive normative distribution of CIMT and to determine its cOrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population. (SCORE India)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of subject informed consent
- •Female or male aged 30 years and over
排除标准
- •Subjects with established cardiovascular event
- •Intake of lipid lowering drug in the past 3 month
- •Subjects with known hypersensitivity to carotid bulb
- •Pregnant or lactating women
结局指标
主要结局
CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
时间窗: at visit 1
次要结局
未报告次要终点