Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01552109
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2012-03-09
Brief Title:
Stable Angina Observational Registry
Sponsor:
Medtronic Vascular
Organization:
Medtronic Vascular
Study Overview
Official Title:
STable Angina obseRvational Registry
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
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 inclusionexclusion 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
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 inclusionexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None