Clinical trial NCT00169871: Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia
Official title: Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief 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.

Detailed 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.

Eligibility criteria: 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...)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Lipid Research Center, CHUL Research Center
state: Quebec
Study officials:
affiliation: CHUL Research Center
name: Jean Bergeron, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: