Primary Care Audit of Global Risk Management (PARADIGM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Milan Gupta, Canadian Cardiovascular Research Network
ClinicalTrials.gov Identifier:
NCT00950703
First received: July 31, 2009
Last updated: December 16, 2013
Last verified: December 2013
  Purpose
  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.

Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Primary Care Audit of Global Risk Management

Resource links provided by NLM:


Further study details as provided by Canadian Cardiovascular Research Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood serum.


Enrollment: 3015
Study Start Date: March 2009
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care clinics.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950703

Locations
Canada, Ontario
CCRN
Brampton, Ontario, Canada, L6Z 4N5
Sponsors and Collaborators
Canadian Cardiovascular Research Network
AstraZeneca
Investigators
Principal Investigator: Milan K Gupta, MD Canadian Cardiovascular Research Network
Principal Investigator: Subodh Verma, MD Canadian Cardiovascular Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Milan Gupta, MD, Canadian Cardiovascular Research Network
ClinicalTrials.gov Identifier: NCT00950703     History of Changes
Other Study ID Numbers: D3560L00086
Study First Received: July 31, 2009
Last Updated: December 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Cardiovascular Research Network:
Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014