- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hu da yi, Dr.
- Phone Number: 8601088324876
- Email: dayi.hu@medmail.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peiking University People' Hospital
-
Contact:
- Ding Rong Jing, Dr.
- Phone Number: 0108688325940
- Email: drj2003@sina.com
-
Sub-Investigator:
- Ding rong jing, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
regions,hospitals,age, gender, risk levels, comorbidity,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities
Time Frame: 6months
|
6months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality
Time Frame: 6months
|
6months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hu da yi, Dr., Chinese Society of Cardiology
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-271-0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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