- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01552109
Stable Angina Observational Registry (STAR)
STable Angina obseRvational Registry
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New Delhi, Indien, 110032
- East Delhi Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10037399DOC
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