A Registration Study for Dyslipidemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02223143
First received: August 18, 2014
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most important risk factor in the development of atherosclerosis in human beings. In Taiwan, the rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and 17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and 13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with statins has in the last decade become part of the standard treatment regimen in patients with dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in Taiwan. It is necessary to have rationalized and balanced guideline for the management of dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data. Because all these trials were conducted in Caucasians and no large-scaled end-point research about the lipid lowering therapy (LLT) was published in Asians before, this registry study attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason. The lipid profile change, myopathy, or liver enzyme change after the LLT will also be recorded.


Condition
Atherosclerotic Vascular Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Registration Study for Primary and Secondary Prevention in Dyslipidemic Taiwanese

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The time to first occurrence of a major cardiovascular event [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The major CV (cardiovascular) event will be defined as CV death, hospitalization for nonfatal MI (myocardial infarction) or stroke, or cardiac arrest with resuscitation


Secondary Outcome Measures:
  • Composite cardiovascular outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The composite cardiovascular (CV) outcome will be any CV events (any major CV events plus hospitalization for any revascularization procedure, unstable angina, or congestive heart failure, and peripheral arterial disease, defined as new clinical diagnosis or hospitalization for such disease). In addition, individual components of the composite end points will be also prespecified as secondary outcomes, as will all-cause mortality.


Other Outcome Measures:
  • The biochemistry change [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    The tertiary objective of this trial is to evaluate the biochemistry change of lipid profile change, myopathy, or liver enzyme change after the lipid lowering therapy.


Estimated Enrollment: 35000
Study Start Date: January 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Detailed Description:

This is a registry study to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason.

All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place yearly thereafter for 5 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.

Criteria

Inclusion Criteria:

  • One with atherosclerotic vascular diseases
  • One without ASVD but with at least 1 CV risk factor
  • Apparent healthy persons

Exclusion Criteria:

  • One with hemodynamically significant valvular or congenital heart disease
  • One with any non-cardiovascular diseases which may affect prognosis
  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: NCT02223143

Contacts
Contact: C C W +886-2-23123456 ext 88560 chauchungwu@ntu.edu.tw
Contact: P Y C +886-2-23123456 ext 88558 utitis3232@gmail.com

Locations
Taiwan
NTUH Recruiting
Taipei, Taiwan
Contact: C C W    886-2-23123456 ext 88560    chauchungwu@ntu.edu.tw   
Sub-Investigator: P Y C         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: C C W chauchungwu@ntu.edu.tw
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02223143     History of Changes
Other Study ID Numbers: 200910021R
Study First Received: August 18, 2014
Last Updated: August 21, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

Keywords provided by National Taiwan University Hospital:
Lipid lowering therapy

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014