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Trial record 1 of 1 for:    NCT00175240
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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.
 
ClinicalTrials.gov Identifier: NCT00175240
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 28, 2015
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
Pfizer
Information provided by:
University of Alberta

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE March 2005
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 1. Provision of other proven efficiacious 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/buproprion.
  • 4. Repeat fasting lipid panel within 6 months post-angiogram.
  • 5. Proportion of patients achieving target LDL-C of 2.5mmol/l or less.
  • 6.Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing the Secondary Prevention of Coronary Artery Disease
Official Title  ICMJE Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Coronary Disease
  • Ischemic Heart Disease
Intervention  ICMJE Behavioral: Evidence summaries endorsed by local opinion leaders
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00175240
Other Study ID Numbers  ICMJE UofA M2022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • Heart and Stroke Foundation of Canada
  • Alberta Heritage Foundation for Medical Research
  • Pfizer
Investigators  ICMJE
Principal Investigator: Finlay McAlister, MD,MSc University of Alberta
PRS Account University of Alberta
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP