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Dyslipidemia International Survey-China (DYSIS-China)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732952
Recruitment Status : Unknown
Verified November 2012 by Hu Dayi, Chinese Society of Cardiology.
Recruitment status was:  Recruiting
First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Information provided by (Responsible Party):
Hu Dayi, Chinese Society of Cardiology

Brief Summary:

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 or disease
the Prevalence,Lipid Abnormalities,

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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Dyslipidemia International Survey - China
Study Start Date : February 2012
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2012

Group/Cohort
regions,hospitals,age, gender, risk levels, comorbidity,



Primary Outcome Measures :
  1. the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities [ Time Frame: 6months ]

Other Outcome Measures:
  1. explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality [ Time Frame: 6months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732952


Contacts
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Contact: Hu da yi, Dr. 8601088324876 dayi.hu@medmail.com.cn

Locations
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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.         
Sponsors and Collaborators
Chinese Society of Cardiology
Investigators
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Principal Investigator: Hu da yi, Dr. Chinese Society of Cardiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hu Dayi, Chinese Society of Cardiology
ClinicalTrials.gov Identifier: NCT01732952    
Other Study ID Numbers: 0000-271-0
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: November 26, 2012
Last Verified: November 2012
Keywords provided by Hu Dayi, Chinese Society of Cardiology:
the prevalence,lipid abnormalities,CV risks
Additional relevant MeSH terms:
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Congenital Abnormalities
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases