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

Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00684151

Enrollment

1240

Registered

2008-05-26

Start date

2008-04-30

Completion date

2011-11-30

Last updated

2011-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Lipid-lowering

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Evidence of high cardiovascular risk * Dyslipidemic currently being treated with the same therapy for at least 3 months

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

Design outcomes

Primary

Measure	Time frame
LDL-cholesterol	June2008

Secondary

Measure	Time frame
Survival	June 2011

Countries

Thailand

Outcome results