Enhancing the Secondary Prevention of Coronary Artery Disease

Coronary Disease Clinical Trial

Official title:

Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175240
• Other study ID #: UofA M2022
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 25, 2015
• Start date: March 2005
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 2015
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Evidence summaries endorsed by local opinion leaders

Locations

Country	Name	City	State
Canada	University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research, Heart and Stroke Foundation of Canada, Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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 2 — View 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. Ca — View Citation

Outcome

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