- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01552109
Stable Angina Observational Registry (STAR)
STable Angina obseRvational Registry
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New Delhi, Inde, 110032
- East Delhi Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10037399DOC
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