Stable Angina Observational Registry

Stable Angina Clinical Trial

— STAR  

Official title:

STable Angina obseRvational Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552109
• Other study ID #: 10037399DOC
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: October 3, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: CLINICOM
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2079
• Est. completion date: December 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Locations

Country	Name	City	State
India	East Delhi Clinic	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

India,