Coronary DiseasePhase 4NCT00175240
Enhancing the Secondary Prevention of Coronary Artery Disease
A Phase 4 study testing Evidence summaries endorsed by local opinion leaders in people with Coronary Disease and Ischemic Heart Disease, run by University of Alberta at 1 site in Canada.
Trial summary
People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Ischemic Heart Disease
- What is being tested?
- Evidence summaries endorsed by local opinion leaders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 480 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Jul 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (> or equal to 50% stenosis in at least one vessel).
Who cannot join
- no fasting lipid panel within the previous 6 weeks
- on a statin at maximal dose
- on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006) and LDL-C is 2.0 mmol/L or less (after Sept 2006)
- not on a statin and LDL-C is 1.8 mmol/L or less
- acute myocardial infarction or cardiogenic shock
- require emergency bypass surgery following catheterization
- contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)
Edmonton, Alberta, T6G 2B7
About this study
Official title: Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)
People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. This study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition.
Read the detailed description
BACKGROUND: Despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with Coronary Artery Disease (CAD) are not offered all possible therapies for the prevention of myocardial infarction or death. For example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ACE inhibitors, beta-blockers and antiplatelet agents are under-prescribed.
Multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, CME, conferences, etc) are usually ineffective in altering practice. Clearly novel interventions to improve the quality of prescribing are needed. Local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. Few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as CAD.
HYPOTHESIS: This trial will test 2 quality improvement interventions. The principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with CAD compared to usual care? The secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with CAD compared to usual care? Does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?
- Conditions
- Coronary Disease, Ischemic Heart Disease
- Being tested
- Evidence summaries endorsed by local opinion leaders
- Keywords
- Coronary disease, quality improvement, knowledge translation
- Medical subject headings
- Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence summaries endorsed by local opinion leadersBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
Secondary outcomes (6)
Provision of other proven efficacious medications for coronary artery disease by 6 months including ACE inhibitors, beta-blockers and antiplatelet agents.
Changes in the provision of other lipid lowering medications.
Smoking rates - receipt of smoking cessation advice/nicotine replacement products/bupropion.
Repeat fasting lipid panel within 6 months post-angiogram.
Proportion of patients achieving target LDL-C of 2.0mmol/l or less.
Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2011
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research, Pfizer
- Investigators
- Finlay McAlister, MD,MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175240
- Sponsor's protocol ID
- UofA M2022
- Status last verified
- Jul 2015
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jul 2015
- Results posted
- No
Publications
McAlister FA, Fradette M, Graham M, Majumdar SR, Ghali WA, Williams R, Tsuyuki RT, McMeekin J, Grimshaw J, Knudtson ML. A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240]. Implement Sci. 2006 May 6;1:11. doi: 10.1186/1748-5908-1-11.
PubMed 16722548McAlister FA, Fradette M, Majumdar SR, Williams R, Graham M, McMeekin J, Ghali WA, Tsuyuki RT, Knudtson ML, Grimshaw J. The Enhancing Secondary Prevention in Coronary Artery Disease trial. CMAJ. 2009 Dec 8;181(12):897-904. doi: 10.1503/cmaj.090917. Epub 2009 Nov 23.
PubMed 19933787McAlister FA, Majumdar SR, Lin M, Bakal J, Fradette M, Anderson T. Cholesterol end points predict outcome in patients with coronary disease: quality improvement metrics from the enhancing secondary prevention in coronary artery disease (ESP-CAD) trial. Can J Cardiol. 2014 Dec;30(12):1627-32. doi: 10.1016/j.cjca.2014.07.008. Epub 2014 Jul 16.
PubMed 25307535
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)
- ClinicalTrials.gov ID
- NCT00175240
- Acronym / sponsor ID
- UofA M2022
- Conditions
- Coronary Disease, Ischemic Heart Disease
- Keywords
- Coronary disease, quality improvement, knowledge translation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research, Pfizer
- Study start
- Mar 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Sep 2005 (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.
People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. This study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition.
Detailed description
BACKGROUND: Despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with Coronary Artery Disease (CAD) are not offered all possible therapies for the prevention of myocardial infarction or death. For example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ACE inhibitors, beta-blockers and antiplatelet agents are under-prescribed.
Multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, CME, conferences, etc) are usually ineffective in altering practice. Clearly novel interventions to improve the quality of prescribing are needed. Local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. Few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as CAD.
HYPOTHESIS: This trial will test 2 quality improvement interventions. The principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with CAD compared to usual care? The secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with CAD compared to usual care? Does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (> or equal to 50% stenosis in at least one vessel).
Key exclusion criteria (7 listed)
- no fasting lipid panel within the previous 6 weeks
- on a statin at maximal dose
- on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006) and LDL-C is 2.0 mmol/L or less (after Sept 2006)
- not on a statin and LDL-C is 1.8 mmol/L or less
- acute myocardial infarction or cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence summaries endorsed by local opinion leaders | Behavioural | – |
Primary outcome
Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
6 secondary outcomes
Provision of other proven efficacious medications for coronary artery disease by 6 months including ACE inhibitors, beta-blockers and antiplatelet agents.
Changes in the provision of other lipid lowering medications.
Smoking rates - receipt of smoking cessation advice/nicotine replacement products/bupropion.
Repeat fasting lipid panel within 6 months post-angiogram.
Proportion of patients achieving target LDL-C of 2.0mmol/l or less.
Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.
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 28 Jul 2015.
- Background: PubMed 16722548McAlister FA, Fradette M, Graham M, Majumdar SR, Ghali WA, Williams R, Tsuyuki RT, McMeekin J, Grimshaw J, Knudtson ML. A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240]. Implement Sci. 2006 May 6;1:11. doi: 10.1186/1748-5908-1-11.
- Results publication: PubMed 19933787McAlister FA, Fradette M, Majumdar SR, Williams R, Graham M, McMeekin J, Ghali WA, Tsuyuki RT, Knudtson ML, Grimshaw J. The Enhancing Secondary Prevention in Coronary Artery Disease trial. CMAJ. 2009 Dec 8;181(12):897-904. doi: 10.1503/cmaj.090917. Epub 2009 Nov 23.
- Results publication: PubMed 25307535McAlister FA, Majumdar SR, Lin M, Bakal J, Fradette M, Anderson T. Cholesterol end points predict outcome in patients with coronary disease: quality improvement metrics from the enhancing secondary prevention in coronary artery disease (ESP-CAD) trial. Can J Cardiol. 2014 Dec;30(12):1627-32. doi: 10.1016/j.cjca.2014.07.008. Epub 2014 Jul 16.
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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.
Finlay McAlister, MD,MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evidence summaries endorsed by local opinion leaders in people with Coronary Disease and Ischemic Heart Disease, run by University of Alberta 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 1 inclusion and 7 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 28 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.. 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 NCT00175240, which also lists 3 linked publications.
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 28 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.