跳至主要内容
临床试验/CTRI/2012/12/003232
CTRI/2012/12/003232已完成不适用

A prospective observational study to examine the risk factor profile of premature Coronary Artery Disease (CAD) in Indians

Lotus Clinical Research Academy21 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年12月17日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,000
试验地点
21
主要终点
risk factor profile of premature CAD in young Indian men (below 55 years) and women (below 65 years).

研究概览

简要总结

This is a multicentre prospective observational study designed to examine the risk factor profile of Coronary Artery Disease in the study cohort of young. This study aims at a better understanding of the risk factors of CAD by examining patients who have an established CAD. Since the major cause of CAD in the younger age group is erratic lifestyle, eating habits and lack of exercise, this study will give a better understanding of the impact of health interventions within the Indian community. This monitoring plan is applicable to the Monitoring team of Lotus Clinical Research Academy Private Limited.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All patients included in the study should satisfy the following criteria.
  • •Age: Male patients who are less than 55 years and female patients who are less than 65 years of age •Symptomatic for CAD or established CAD by one or all of the methods described in Section 5.
  • Willing to sign an informed consent.

排除标准

  • 1.Age: Male patients who are greater than 55 years and female patients who are greater than 65 years of age
  • There is an absence of CAD or diagnosis of CAD by other methods than those •by a definite imaging technique •symptomatic for CAD and stress test positive •who have had previous Coronary artery bypass surgery (CABG) or Percutaneous Transluminal coronary angioplasty (PTCA).
  • or a doubtful diagnosis of CAD.
  • Unwilling to participate in the study or sign the informed consent.

结局指标

主要结局

risk factor profile of premature CAD in young Indian men (below 55 years) and women (below 65 years).

时间窗: 02 years

次要结局

  • 1.To assess and examine treatment variables and suggested lifestyle changes across regions pre and post-intervention.(2.To compare the prevalence of MI in the study group based on the old and new classification of MI.)

研究者

发起方
Lotus Clinical Research Academy
申办方类型
Contract research organization

研究点 (21)

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