Stable Angina Observational Registry (STAR)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT01552109

First received: March 9, 2012

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 9, 2012
Last Updated Date	April 5, 2013
Start Date ^ICMJE	January 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01552109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Stable Angina Observational Registry
Official Title ^ICMJE	STable Angina obseRvational Registry
Brief 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: 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 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: Subject has a history of Acute Coronary Syndrome Subject has a history of prior revascularization Subject has a history of previous MI Subject has new onset angina with symptoms less than one month Objectives: Describe the demographic and medical profile of subjects diagnosed with stable angina by non-interventional consulting physicians in India Describe the diagnostic pathway prescribed by non-interventional consulting physicians and adopted by stable angina subjects in India Describe the management of stable angina by non-interventional consulting physicians and undertaken by subjects in India
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study 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.
Condition ^ICMJE	Stable Angina
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	2079
Estimated Completion Date	December 2013
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria Subject must meet all of the following criteria to be eligible for inclusion in the trial: 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 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: Subject has a history of Acute Coronary Syndrome Subject has a history of prior revascularization Subject has a history of previous MI Subject has new onset angina with symptoms less than one month
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01552109
Other Study ID Numbers ^ICMJE	10037399DOC
Has Data Monitoring Committee	No
Responsible Party	Medtronic Vascular
Study Sponsor ^ICMJE	Medtronic Vascular
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Vascular
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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