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PARADIGM: Primary Care Audit of Global Risk Management

Sponsor
Canadian Collaborative Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT00950703
Collaborator
AstraZeneca (Industry)
3,015
Enrollment
1
Location
78
Duration (Months)
38.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. Assessing the perception of Canadian Primary Care Physicians towards global cardiovascular risk assessment.

  2. Correlating physician perceptions to actual practice data, gathered via a retrospective chart audit.

  3. Evaluating the impact of a prospective educational and peer-practice pattern intervention on future assessment o cardiovascular risk and

  4. Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an adjunct to global risk prediction.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The majority of cardiovascular events occur in people with low to intermediate Framingham Risk Score. Despite evidence-based guidelines, the appropriate use of lipid-lowering therapies in this population remains limited and controversial. Strategies to refine risk stratification in primary prevention have been poorly adopted. Dissemination of practice-changing trials and closing the care gap in primary care remain a priority and a challenge. Considerable confusion remains regarding the optimal application of lipid-lowering therapy in primary prevention. Importantly, it remains largely unknown which tools or techniques are used by Canadian primary care physicians to identify global vascular risk, and what barriers exist to implementing risk reduction therapies in such individuals.

    For primary prevention of patients with normal levels of LDL-Cholesterol who are at increased risk on the basis of elevated hsCRP, it remains unproven whether statin therapy will effectively reduce vascular event rates. The JUPITER trial was launched in 2003 comparing rosuvastatin with placebo in 18,000 primary prevention patients with LDL-cholesterol of less than 3.36mM who also have an hsCRP of greater than 2 mg/L. This trial has been stopped early due to unequivocal morbidity and mortality benefits in favor of the treatment strategy, and the final results will be available in early November, 2008. JUPITER, once published, will require a major change in physician behavior with respect to screening and treating cardiovascular risk.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3015 participants
    Time Perspective:
    Prospective
    Official Title:
    Primary Care Audit of Global Risk Management
    Study Start Date :
    Mar 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. The Primary objective of the PARADIGM study is to evaluate the impact of an educational and peer-practice pattern intervention on primary care physician behavior towards global cardiovascular risk prediction in otherwise healthy individuals. [1 year]

    Secondary Outcome Measures

    1. Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1). [1 year]

    2. Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Men more than or equal to 40 yrs old and women more than or equal to 50 yrs old;

    2. No previous history of atherosclerosis( angina, TIA, myocardial infarction, stroke, peripheral arterial disease);

    3. Non-diabetic;

    4. Absence of lipid lowering treatment (current or past).

    Exclusion Criteria:

    1. Known history of atherosclerosis or diabetes;

    2. Use of lipid lowering therapies (statins, ezetimibe, fibrates, niacin, fish oil);

    3. Use of postmenopausal hormone replacement therapy;

    4. Use of immunosuppressant's or steroids;

    5. Active liver disease or hepatic dysfunction(ALT>2times the ULN);

    6. Active renal disease (baseline Creatinine >170 umol/L);

    7. History of malignancy within the past 5-years;

    8. Chronic inflammatory conditions such as arthritis, lupus or inflammatory bowel disease;

    9. Known alcohol or drug abuse;

    10. Failure to provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCRN Brampton Ontario Canada L6Z 4N5

    Sponsors and Collaborators

    • Canadian Collaborative Research Network
    • AstraZeneca

    Investigators

    • Principal Investigator: Milan K Gupta, MD, Canadian Collaborative Research Network
    • Principal Investigator: Subodh Verma, MD, Canadian Collaborative Research Network

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dr. Milan Gupta, MD, Canadian Collaborative Research Network
    ClinicalTrials.gov Identifier:
    NCT00950703
    Other Study ID Numbers:
    • D3560L00086
    First Posted:
    Aug 3, 2009
    Last Update Posted:
    Oct 14, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Dr. Milan Gupta, MD, Canadian Collaborative Research Network
    Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Oct 14, 2015