- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Hu da yi, Dr.
- Telefonnummer: 8601088324876
- E-mail: dayi.hu@medmail.com.cn
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100044
- Rekruttering
- Peiking University People' Hospital
-
Kontakt:
- Ding Rong Jing, Dr.
- Telefonnummer: 0108688325940
- E-mail: drj2003@sina.com
-
Underforsker:
- Ding rong jing, Dr.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- 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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
---|
regions,hospitals,age, gender, risk levels, comorbidity,
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities
Tidsramme: 6months
|
6months
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality
Tidsramme: 6months
|
6months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Hu da yi, Dr., Chinese Society of Cardiology
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0000-271-0
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