Dyslipidemia International Survey-China (DYSIS-China)

November 23, 2012 updated by: Hu Dayi, Chinese Society of Cardiology

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

Unknown

Study Type

Observational

Enrollment (Anticipated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peiking University People' Hospital
        • Contact:
        • Sub-Investigator:
          • Ding rong jing, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hu da yi, Dr., Chinese Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 26, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

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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