CClinicalTrials.gg
CompletedNCT00950703PARADIGMUpdated Oct 14, 2015

Primary Care Audit of Global Risk Management

An observational study in Cardiovascular Diseases, sponsored by Canadian Collaborative Research Network. Completed at 1 site in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Canadian Collaborative Research Network · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
3,015
Ages
40 Years and older
Sex
All
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Study 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.
Read the 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.

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 3,015 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Canadian Collaborative Research Network is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Primary care clinics.

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

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.
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Study design

Time perspective
Prospective
Enrollment
3,015 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1).

    Time frame: 1 year

  2. Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment.

    Time frame: 1 year

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Study locations

1 site
  • CCRN
    Brampton, Ontario L6Z 4N5, Canada
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References and documents

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. PubMed 29474565 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00950703
Lead sponsor
Canadian Collaborative Research Network
Collaborators
AstraZeneca
Responsible party
Dr. Milan Gupta (MD, Canadian Collaborative Research Network) — Principal investigator
First posted
Aug 3, 2009
Start date
Mar 2009
Primary completion
Jun 2015
Completion
Sep 2015
Last update
Oct 14, 2015

Study contacts

Milan K Gupta, MD
principal investigator · Canadian Collaborative Research Network
Subodh Verma, MD
principal investigator · Canadian Collaborative Research Network

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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