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Stable Angina Observational Registry (STAR)

3. oktober 2014 opdateret af: Medtronic Vascular

STable Angina obseRvational Registry

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.

Studieoversigt

Status

Afsluttet

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:

  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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2079

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • New Delhi, Indien, 110032
        • East Delhi Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult, male or female subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and who meet the study inclusion/exclusion criteria.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

9. marts 2012

Først indsendt, der opfyldte QC-kriterier

12. marts 2012

Først opslået (Skøn)

13. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Stabil angina

Abonner