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Dyslipidemia International Survey-China (DYSIS-China)

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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

Tracking Information
First Submitted Date November 20, 2012
First Posted Date November 26, 2012
Last Update Posted Date November 26, 2012
Study Start Date February 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2012)
the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 23, 2012)
assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities [ Time Frame: 6months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2012)
explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality [ Time Frame: 6months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Dyslipidemia International Survey-China
Official Title Dyslipidemia International Survey - China
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition the Prevalence,Lipid Abnormalities,
Intervention Not Provided
Study Groups/Cohorts regions,hospitals,age, gender, risk levels, comorbidity,
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 23, 2012)
25000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01732952
Other Study ID Numbers 0000-271-0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hu Dayi, Chinese Society of Cardiology
Study Sponsor Chinese Society of Cardiology
Collaborators Not Provided
Investigators
Principal Investigator: Hu da yi, Dr. Chinese Society of Cardiology
PRS Account Chinese Society of Cardiology
Verification Date November 2012