the Prevalence,Lipid Abnormalities, Clinical Trial
— DYSIS-ChinaOfficial title:
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.
| Status | Recruiting |
| Enrollment | 25000 |
| Est. completion date | December 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patient is an outpatient > 45 years of age 2. Patient is currently* treated with a statin 3. 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 4. 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. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| China | Peiking University People' Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese Society of Cardiology |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality | 6months | No | |
| Primary | the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug | 6 months | No | |
| Secondary | assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities | 6months | No |