Clinical trial NCT01552109: Stable Angina Observational Registry
Official title: STable Angina obseRvational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Keywords: symptomatic stable angina
subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and meets the inclusion/exclusion criteria
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 2079
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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:

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: East Delhi Clinic
Study officials:
References: