Primary Care Audit of Global Risk Management (PARADIGM)
|ClinicalTrials.gov Identifier: NCT00950703|
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : October 14, 2015
- Assessing the perception of Canadian Primary Care Physicians towards global cardiovascular risk assessment.
- Correlating physician perceptions to actual practice data, gathered via a retrospective chart audit.
- Evaluating the impact of a prospective educational and peer-practice pattern intervention on future assessment o cardiovascular risk and
- Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an adjunct to global risk prediction.
|Condition or disease|
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|
|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|
- 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 ]
- Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1). [ Time Frame: 1 year ]
- Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment. [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950703
|Brampton, Ontario, Canada, L6Z 4N5|
|Principal Investigator:||Milan K Gupta, MD||Canadian Collaborative Research Network|
|Principal Investigator:||Subodh Verma, MD||Canadian Collaborative Research Network|