Primary Care Audit of Global Risk Management

Cardiovascular Diseases Clinical Trial

— PARADIGM  

Official title:

Primary Care Audit of Global Risk Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950703
• Other study ID #: D3560L00086
• Status: Completed
• Phase: N/A
• First received: July 31, 2009
• Last updated: October 13, 2015
• Start date: March 2009
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Canadian Cardiovascular Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3015
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
Canada	CCRN	Brampton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Cardiovascular Research Network	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1).		1 year	No
Secondary	Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment.		1 year	No

External Links

•   018 Contemporary trends in hypertension in canada: Insight from the primary care audit of global risk management (paradigm) study
•   Abstract 11095: Prevalence of Metabolic Syndrome in Healthy Middle-Aged Adults: Insights from the Primary Care Audit of Global Risk Management (PARADIGM) Study
•   Abstract 11116: Prevalence of Impaired Fasting Glucose in Healthy Middle-Aged Adults: Insights from the Primary Care Audit of Global Risk Management (PARADIGM) Study
•   Abstract 14502: Variability in Traditional and Novel Cardiovascular Risk Factors by Ethnic Origin: Insights from the Primary Care Audit of Global Risk Management (PARADIGM) Study
•   Abstract 16946: Accuracy of Cardiovascular (cv) Risk Stratification by Canadian Primary Care Physicians: Preliminary Results From the Primary Care Audit of Global Risk Management (PARADIGM) Study
•   Abstract 9164: Who Receives ASA for Primary Prevention 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