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Completed

NCT Number: NCT01552109

Stable Angina Observational Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Delhi Clinic

New Delhi, 110032, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Acronym: STAR

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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