Primary Care Audit of Global Risk Management

NCT ID: NCT00950703

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3015 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Canadian Collaborative Research Network

OTHER

Sponsor Role: lead

Responsible Party

Dr. Milan Gupta

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milan K Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Collaborative Research Network

Subodh Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Collaborative Research Network

Locations

CCRN

Brampton, Ontario, Canada

Countries

Canada

References

Law TK, Yan AT, Gupta A, Kajil M, Tsigoulis M, Singh N, Verma S, Gupta M. Primary prevention of cardiovascular disease: global cardiovascular risk assessment and management in clinical practice. Eur Heart J Qual Care Clin Outcomes. 2015 Jul 1;1(1):31-36. doi: 10.1093/ehjqcco/qcv002.

Reference Type: DERIVED

PMID: 29474565 (View on PubMed)

Other Identifiers

D3560L00086

Identifier Type: -

Identifier Source: org_study_id