Overview

This trial is active, not recruiting.

Condition stable angina
Sponsor Medtronic Vascular
Start date January 2012
End date August 2012
Trial size 2079 participants
Trial identifier NCT01552109, 10037399DOC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title STable Angina obseRvational Registry
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Medtronic Vascular.