Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

Dyslipidemia Clinical Trial

Official title:

Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169871
• Other study ID #: DC-452-0011
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 20, 2007
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2006
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The objective of this proposal is to study the applicability of the hs-CRP assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic population with or without CHD are currently evaluated.

Description:

Coronary heart disease (CHD) is the major cause of death in the developed world. Cholesterol screening has been used as a tool to identify individuals who are at increased risk of developing future coronary events, but almost one-half of patients who develop myocardial infarction have either normal or only moderately increased serum cholesterol concentrations. In the last years, experimental and clinical evidence has demonstrated that atherosclerosis is not simply a disease of lipid deposits. Rather, there is growing recognition that CHD has an inflammatory component which plays a critical role in the arterial plaque rupture that triggers most episodes of coronary thrombosis. In the last years, C-reactive protein (CRP), an exquisitely sensitive marker of systemic inflammation, has emerged as a powerful predictor of cardiovascular diseases, in particular of CHD, beyond what can be estimated by traditional risk factors. The availability of high-sensitivity (hs) CRP assays has enabled the detection of even low-grade inflammatory responses that have previously been regarded as clinically not meaningful. However, for hs-CRP to make the transition from epidemiological and clinical research to the routine clinical setting, several important issues must be satisfactorily addressed.

Therefore, the overall objective of this proposal is to study the applicability of the hs-CRP assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic population with or without CHD are currently evaluated and to evaluate hs-CRP response to statins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• metabolically stable in the last 3 months for weight (+/- 1 kg), lipid profile (+/- 15 % variability), infection (no symptoms for viral or bacterial illness), inflammation (absence of nonspecific symptoms for arthritis, normal blood sedimentation and protein electrophoresis for acute phase reactants) and no change of usual habits (ex. diet/exercise) or medications (ex. drugs)

• CHD patients will have to be stable (based on cardiac symptoms and ECG) during the last 3 months and diabetic patients will be required to have stable glycemia (HbA1c < 7,5 %) in the last 6 months.

Exclusion Criteria:

• history of drug or alcohol abuse

• uncontrolled liver, thyroid or kidney functions

• other drugs known to affect lipid levels or insulin resistance (antiprotease inhibitors, oral contraceptives...)

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Locations

Country	Name	City	State
Canada	Lipid Research Center, CHUL Research Center	Sainte-Foy	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	AstraZeneca

Country where clinical trial is conducted

Canada,