Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00169871
First received: September 13, 2005
Last updated: April 20, 2007
Last verified: May 2006
  Purpose

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.


Condition Phase
Dyslipidemia
Phase 4

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Estimated Enrollment: 1000
Study Start Date: March 2005
Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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...)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169871

Locations
Canada, Quebec
Lipid Research Center, CHUL Research Center
Sainte-Foy, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
AstraZeneca
Investigators
Principal Investigator: Jean Bergeron, MD MSc FRCPC CHUL Research Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00169871     History of Changes
Other Study ID Numbers: DC-452-0011
Study First Received: September 13, 2005
Last Updated: April 20, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014