Dyslipidemia International Survey-China (DYSIS-China)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Chinese Society of Cardiology
Sponsor:
Information provided by (Responsible Party):
Hu Dayi, Chinese Society of Cardiology
ClinicalTrials.gov Identifier:
NCT01732952
First received: November 20, 2012
Last updated: November 23, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Chinese Society of Cardiology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities [ Time Frame: 6months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732952

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

Locations
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
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 October 22, 2014