Cardiovascular DiseasesPARADIGMNCT00950703
Primary Care Audit of Global Risk Management
An observational study of Cardiovascular Diseases, run by Canadian Collaborative Research Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 3,015 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinics.
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
Evaluate the prevalence of classic and novel markers of risk (hsCRP and ApoB/ApoA1).
Measured: 1 year
Evaluate within a sub-study, the feasibility of carotid atherosclerosis assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Collaborative Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Dr. Milan Gupta, Canadian Collaborative Research Network
- Investigators
- Milan K Gupta, MD, Principal investigator, Canadian Collaborative Research NetworkSubodh Verma, MD, Principal investigator, Canadian Collaborative Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950703
- Sponsor's protocol ID
- D3560L00086
- Acronym
- PARADIGM
- Status last verified
- Oct 2015
- First submitted
- 31 Jul 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Audit of Global Risk Management
- ClinicalTrials.gov ID
- NCT00950703
- Acronym / sponsor ID
- PARADIGM / D3560L00086
- Conditions
- Cardiovascular Diseases
- Keywords
- Assessing the perceptions of Canadian Primary care physicians towards global Cardiovascular risk assessment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,015 participants (actual)
- Lead sponsor
- Canadian Collaborative Research NetworkUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 29474565Law 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.
- Characteristics of Non-Diabetic Middle-Aged Adults With Chronic Kidney Disease (CKD) - Insight From the Paradigm RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan K Gupta, MD principal investigator
Canadian Collaborative Research Network
Subodh Verma, MD principal investigator
Canadian Collaborative Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Canadian Collaborative Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.