- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01732952
Dyslipidemia International Survey-China (DYSIS-China)
Dyslipidemia International Survey - China
This cross-sectional, non-interventional, and observational study will assess the lipid profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients achieving treatment to goal according to national and international lipid management guidelines) during a single visit to their physicians on an outpatient basis in 6 representative geo-economic regions in China: Northeast, North, East, South, Southwest, and Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community hospitals/health centers). The investigators will primarily be cardiologists, endocrinologists, neurologists, gerontologists, internists, or other physicians who are representative of the general population of physicians managing patients with dyslipidemia and/or at high risk for cardiovascular events likely to be treated with lipid-modifying drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and cardiovascular treatments will be documented in a single visit through patient clinical examination and chart review.
DYSIS-China is part of a string of epidemiological studies that share the same master protocol, which has been conducted in different countries mainly in Europe and Canada. The analysis of the pooled studies including overall data and cross-country comparisons is the subject of a distinct protocol.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 100044
- Reclutamento
- Peiking University People' Hospital
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Contatto:
- Ding Rong Jing, Dr.
- Numero di telefono: 0108688325940
- Email: drj2003@sina.com
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Sub-investigatore:
- Ding rong jing, Dr.
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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
- Patient is an outpatient > 45 years of age
- Patient is currently* treated with a statin
- Patient has a documented fasting lipid profile (> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
Patient agrees to participate in the study by giving informed consent.
- Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.
Descrizione
Inclusion Criteria:
- Patient is an outpatient > 45 years of age
- Patient is currently* treated with a statin
- Patient has a documented fasting lipid profile (> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
Patient agrees to participate in the study by giving informed consent.
- Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.
Exclusion Criteria:
1. Patient is currently participating in a clinical trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
|---|
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regions,hospitals,age, gender, risk levels, comorbidity,
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug
Lasso di tempo: 6 months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities
Lasso di tempo: 6months
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6months
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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality
Lasso di tempo: 6months
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6months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hu da yi, Dr., Chinese Society of Cardiology
Pubblicazioni e link utili
Pubblicazioni generali
- Chen Y, Yin C, Li Q, Yu L, Zhu L, Hu D, Sun Y. Misuse of Aspirin and Associated Factors for the Primary Prevention of Cardiovascular Disease. Front Cardiovasc Med. 2021 Sep 3;8:720113. doi: 10.3389/fcvm.2021.720113. eCollection 2021.
- Yan X, Li Y, Dong Y, Wu Y, Li J, Bian R, Hu D. Blood pressure and low-density lipoprotein cholesterol control status in Chinese hypertensive dyslipidemia patients during lipid-lowering therapy. Lipids Health Dis. 2019 Jan 29;18(1):32. doi: 10.1186/s12944-019-0974-y.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
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
- 0000-271-0
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 .