- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01552109
Stable Angina Observational Registry (STAR)
STable Angina obseRvational Registry
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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New Delhi, Indien, 110032
- East Delhi Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Blivande
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10037399DOC
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