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Enhancing the Secondary Prevention of Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175240
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 28, 2015
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
Information provided by:
University of Alberta

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Coronary Disease Ischemic Heart Disease Behavioral: Evidence summaries endorsed by local opinion leaders Phase 4

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)
Study Start Date : March 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Provision of other proven efficacious medications for coronary artery disease by 6 months including ACE inhibitors, beta-blockers and antiplatelet agents.
  2. Changes in the provision of other lipid lowering medications.
  3. Smoking rates - receipt of smoking cessation advice/nicotine replacement products/bupropion.
  4. Repeat fasting lipid panel within 6 months post-angiogram.
  5. Proportion of patients achieving target LDL-C of 2.0mmol/l or less.
  6. Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (> or equal to 50% stenosis in at least one vessel).

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175240

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Canada, Alberta
University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
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Principal Investigator: Finlay McAlister, MD,MSc University of Alberta
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00175240    
Other Study ID Numbers: UofA M2022
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by University of Alberta:
Coronary disease
quality improvement
knowledge translation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases