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Stable Angina Observational Registry (STAR)

2014年10月3日 更新者:Medtronic Vascular

STable Angina obseRvational Registry

The purpose of this study is to describe the clinical profile and current status of the diagnosis and management of stable angina in India by non-interventional consulting physicians (CP) through a large multicenter observational registry.

研究概览

地位

完全的

详细说明

An observational registry on diagnosis and management of stable angina in India Purpose To describe the clinical profile and current status of the diagnosis and management of stable angina in India by non-interventional consulting physicians (CP) through a large multicenter observational registry.

Design A prospective, multi-center, observational registry. Subject Population Adult, male or female subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and who meet the study inclusion/exclusion criteria.

Enrollment:

The study is expected to enroll 1000 to 1500 subjects by 150 - 250 non-interventional consulting physicians. The enrollment period will be around 4 months.

Inclusion criteria

Subject must meet all of the following criteria to be eligible for inclusion in the trial:

  1. Subject has been provisionally diagnosed with stable angina by the CP (consulting physician) during the current visit or within 3 months preceding the current visit
  2. Subject agrees to sign a data release form

Exclusion criteria

Subjects will be excluded from the trial if any of the following criteria are met:

  1. Subject has a history of Acute Coronary Syndrome
  2. Subject has a history of prior revascularization
  3. Subject has a history of previous MI
  4. Subject has new onset angina with symptoms less than one month

Objectives:

  1. Describe the demographic and medical profile of subjects diagnosed with stable angina by non-interventional consulting physicians in India
  2. Describe the diagnostic pathway prescribed by non-interventional consulting physicians and adopted by stable angina subjects in India
  3. Describe the management of stable angina by non-interventional consulting physicians and undertaken by subjects in India

研究类型

观察性的

注册 (实际的)

2079

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • New Delhi、印度、110032
        • East Delhi Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult, male or female subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and who meet the study inclusion/exclusion criteria.

描述

Inclusion criteria

Subject must meet all of the following criteria to be eligible for inclusion in the trial:

  1. Subject has been provisionally diagnosed with stable angina by the CP (consulting physician) during the current visit or within 3 months preceding the current visit
  2. Subject agrees to sign a data release form

Exclusion criteria

Subjects will be excluded from the trial if any of the following criteria are met:

  1. Subject has a history of Acute Coronary Syndrome
  2. Subject has a history of prior revascularization
  3. Subject has a history of previous MI
  4. Subject has new onset angina with symptoms less than one month

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 时间观点:预期

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2012年8月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2012年3月9日

首先提交符合 QC 标准的

2012年3月12日

首次发布 (估计)

2012年3月13日

研究记录更新

最后更新发布 (估计)

2014年10月7日

上次提交的符合 QC 标准的更新

2014年10月3日

最后验证

2014年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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