Clinical Trials Directory

Trials / Completed

CompletedNCT01552109

Stable Angina Observational Registry

STable Angina obseRvational Registry

Status
Completed
Phase
Study type
Observational
Enrollment
2,079 (actual)
Sponsor
Medtronic Vascular · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Conditions

Timeline

Start date
2012-01-01
Primary completion
2012-08-01
Completion
2013-12-01
First posted
2012-03-13
Last updated
2014-10-07

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT01552109. Inclusion in this directory is not an endorsement.