- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01552109
Stable Angina Observational Registry (STAR)
STable Angina obseRvational Registry
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New Delhi, India, 110032
- East Delhi Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Prospettiva
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10037399DOC
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .