Enhancing the Secondary Prevention of Coronary Artery Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
Pfizer
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00175240
First received: September 12, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Coronary Disease
Ischemic Heart Disease
Behavioral: Evidence summaries endorsed by local opinion leaders
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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.

Estimated Enrollment: 480
Study Start Date: March 2005
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175240

Locations
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
Pfizer
Investigators
Principal Investigator: Finlay McAlister, MD,MSc University of Alberta
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00175240     History of Changes
Other Study ID Numbers: UofA M2022
Study First Received: September 12, 2005
Last Updated: May 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Coronary disease
quality improvement
knowledge translation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014