Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
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Purpose
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.
| Condition |
|---|
|
Dyslipidemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand |
- LDL-cholesterol [ Time Frame: June2008 ] [ Designated as safety issue: No ]
- Survival [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
| Enrollment: | 1240 |
| Study Start Date: | April 2008 |
| Study Completion Date: | November 2011 |
| Groups/Cohorts |
|---|
|
1
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
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
Contacts and Locations
Show 49 Study Locations| Study Director: | Bandit Thinkhamrop, Ph.D | Khon Kaen University |
| Principal Investigator: | Songkwan Silaruks, M.D. | Khon Kaen University |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00684151 History of Changes |
| Other Study ID Numbers: | NIS-CTH-DUM-2007/1 |
| Study First Received: | May 22, 2008 |
| Last Updated: | December 9, 2011 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by AstraZeneca:
|
Lipid-lowering |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013