Dyslipidemia International Survey-China (DYSIS-China)
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Purpose
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.
| Condition |
|---|
|
the Prevalence,Lipid Abnormalities, |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Dyslipidemia International Survey - China |
- the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities [ Time Frame: 6months ] [ Designated as safety issue: No ]
- explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality [ Time Frame: 6months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| regions,hospitals,age, gender, risk levels, comorbidity, |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
- 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.
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.
Contacts and Locations| Contact: Hu da yi, Dr. | 8601088324876 | dayi.hu@medmail.com.cn |
| China, Beijing | |
| Peiking University People' Hospital | Recruiting |
| Beijing, Beijing, China, 100044 | |
| Contact: Ding Rong Jing, Dr. 0108688325940 drj2003@sina.com | |
| Sub-Investigator: Ding rong jing, Dr. | |
| Principal Investigator: | Hu da yi, Dr. | Chinese Society of Cardiology |
More Information
No publications provided
| Responsible Party: | Hu Dayi, Chinese Society of Cardiology |
| ClinicalTrials.gov Identifier: | NCT01732952 History of Changes |
| Other Study ID Numbers: | 0000-271-0 |
| Study First Received: | November 20, 2012 |
| Last Updated: | November 23, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese Society of Cardiology:
|
the prevalence,lipid abnormalities,CV risks |
Additional relevant MeSH terms:
|
Congenital Abnormalities Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013