Primary Care Audit of Global Risk Management (PARADIGM)

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 3015

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • CCRN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinics.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Canadian Collaborative Research Network
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Milan K Gupta, MD, Canadian Collaborative Research Network; Principal Investigator: Subodh Verma, MD, Canadian Collaborative Research Network

Publications and helpful links

General Publications

• 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.

Helpful Links

• 018 Contemporary trends in hypertension in canada: Insight from the primary care audit of global risk management (paradigm) study
• Characteristics of Non-Diabetic Middle-Aged Adults With Chronic Kidney Disease (CKD) - Insight From the Paradigm Registry

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 31, 2009
• First Submitted That Met QC Criteria: July 31, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: D3560L00086