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Stable Angina Observational Registry (STAR)

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ClinicalTrials.gov Identifier: NCT01552109
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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.

Condition or disease
Stable Angina

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

Study Type : Observational
Actual Enrollment : 2079 participants
Time Perspective: Prospective
Official Title: STable Angina obseRvational Registry
Study Start Date : January 2012
Primary Completion Date : August 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552109


Locations
India
East Delhi Clinic
New Delhi, India, 110032
Sponsors and Collaborators
Medtronic Vascular

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01552109     History of Changes
Other Study ID Numbers: 10037399DOC
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Medtronic Vascular:
symptomatic stable angina
subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and meets the inclusion/exclusion criteria

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms