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Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand

Completed
Conditions
Dyslipidemia
Registration Number
NCT00684151
Lead Sponsor
AstraZeneca
Brief Summary

The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the hospital will enroll 10 to 40 consecutive patients, depending on case availability on the date conducting the survey, with dyslipidemia and classified as high risk as defined by the protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.

For the second phase, each subject will be followed for survival status at 36 months after enrollment. Such follow-up will be done by searching the Thai National Vital Event Registration Database using subjects' Population Identification Number. All activities regarding case selection and data collection will be done by well trained clinical research associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating Center (SCC) for this project is based and are independent of the investigator. Random auditing visits will also be performed by auditors independent of the SCC. These are to ensure not only high quality data but also protecting right and well being of subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1240
Inclusion Criteria
  • Evidence of high cardiovascular risk
  • Dyslipidemic currently being treated with the same therapy for at least 3 months
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Exclusion Criteria
  • Recent major trauma(within 12 weeks)
  • Recent surgery requiring anesthesia including coronary bypass graft(within 12 weeks)
  • Acute or abrupt change(within 1 month) in usual diet
  • Pregnancy, breast-feeding currently, or postpartum within the last 6 months
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
LDL-cholesterolJune2008
Secondary Outcome Measures
NameTimeMethod
SurvivalJune 2011

Trial Locations

Locations (1)

Research Site

🇹🇭

Maung, Uttaradit, Thailand

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