Primary Care Audit of Global Risk Management (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950703
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Dr. Milan Gupta, Canadian Collaborative Research Network

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
Cardiovascular Diseases

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 Type : Observational
Actual Enrollment : 3015 participants
Time Perspective: Prospective
Official Title: Primary Care Audit of Global Risk Management
Study Start Date : March 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

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. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1). [ Time Frame: 1 year ]
  2. Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Blood serum.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinics.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00950703

Canada, Ontario
Brampton, Ontario, Canada, L6Z 4N5
Sponsors and Collaborators
Canadian Collaborative Research Network
Principal Investigator: Milan K Gupta, MD Canadian Collaborative Research Network
Principal Investigator: Subodh Verma, MD Canadian Collaborative Research Network

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Milan Gupta, MD, Canadian Collaborative Research Network Identifier: NCT00950703     History of Changes
Other Study ID Numbers: D3560L00086
First Posted: August 3, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Dr. Milan Gupta, Canadian Collaborative Research Network:
Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.

Additional relevant MeSH terms:
Cardiovascular Diseases