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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
  Purpose

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
Stable Angina

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: STable Angina obseRvational Registry

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Enrollment: 2079
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552109

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

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01552109     History of Changes
Other Study ID Numbers: 10037399DOC
Study First Received: March 9, 2012
Last Updated: April 5, 2013
Health Authority: India: CLINICOM

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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013