Primary Care Audit of Global Risk Management (PARADIGM)

Canadian Collaborative Research Network

Status: Completed

Conditions: Cardiovascular Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00950703

D3560L00086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,015 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.