Primary Care Audit of Global Risk Management

NCT00950703 | Completed

• 1 other identifier: D3560L00086
• Study Type: observational
• Target: 3,015
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Assessing the perception of Canadian Primary Care Physicians towards global cardiovascular risk assessment.
2. 2.Correlating physician perceptions to actual practice data, gathered via a retrospective chart audit.
3. 3.Evaluating the impact of a prospective educational and peer-practice pattern intervention on future assessment o cardiovascular risk and
4. 4.Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an adjunct to global risk prediction.

Conditions

Cardiovascular Diseases

Keywords

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

Outcome Measures

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.

  1 year

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinics.

You may qualify if:

• Men more than or equal to 40 yrs old and women more than or equal to 50 yrs old;
• No previous history of atherosclerosis( angina, TIA, myocardial infarction, stroke, peripheral arterial disease);
• Non-diabetic;
• Absence of lipid lowering treatment (current or past).

You may not qualify if:

• Known history of atherosclerosis or diabetes;
• Use of lipid lowering therapies (statins, ezetimibe, fibrates, niacin, fish oil);
• Use of postmenopausal hormone replacement therapy;
• Use of immunosuppressant's or steroids;
• Active liver disease or hepatic dysfunction(ALT\>2times the ULN);
• Active renal disease (baseline Creatinine \>170 umol/L);
• History of malignancy within the past 5-years;
• Chronic inflammatory conditions such as arthritis, lupus or inflammatory bowel disease;
• Known alcohol or drug abuse;
• Failure to provide informed consent.

Sponsors & Collaborators

• Canadian Collaborative Research Network: lead
• AstraZeneca: collaborator

Study Sites (1)

CCRN

Brampton, Ontario, L6Z 4N5, Canada

Location

Related Publications (1)

• 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.

  PMID: 29474565 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Milan K Gupta, MD

  Canadian Collaborative Research Network

  PRINCIPAL INVESTIGATOR

• Subodh Verma, MD

  Canadian Collaborative Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 3, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

CA (1)