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Enhancing the Secondary Prevention of Coronary Artery Disease

Primary Purpose

Coronary Disease, Ischemic Heart Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Evidence summaries endorsed by local opinion leaders
Sponsored by
University of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring Coronary disease, quality improvement, knowledge translation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 12, 2005
Last Updated
July 25, 2015
Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00175240
Brief Title
Enhancing the Secondary Prevention of Coronary Artery Disease
Official Title
Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Alberta Heritage Foundation for Medical Research, Pfizer

4. Oversight

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Ischemic Heart Disease
Keywords
Coronary disease, quality improvement, knowledge translation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Evidence summaries endorsed by local opinion leaders
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Provision of other proven efficacious medications for coronary artery disease by 6 months including ACE inhibitors, beta-blockers and antiplatelet agents.
Title
Changes in the provision of other lipid lowering medications.
Title
Smoking rates - receipt of smoking cessation advice/nicotine replacement products/bupropion.
Title
Repeat fasting lipid panel within 6 months post-angiogram.
Title
Proportion of patients achieving target LDL-C of 2.0mmol/l or less.
Title
Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finlay McAlister, MD,MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16722548
Citation
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.
Results Reference
background
PubMed Identifier
19933787
Citation
McAlister 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 Reference
result
PubMed Identifier
25307535
Citation
McAlister 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.
Results Reference
result

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Enhancing the Secondary Prevention of Coronary Artery Disease

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