Back to resultsSecondary Prevention After Coronary Bypass Surgery
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary artery disease, CABG
Eligibility Criteria
Inclusion Criteria:
- Subjects over the age of 18 who will undergo a CABG procedure and who have given written informed consent
Exclusion Criteria:
- Subjects under the age of 18 or who are unable to give consent on their own behald
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Standard care
Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse
Outcomes
Primary Outcome Measures
compliance with medications and lifestyle changes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00843089
Brief Title
Secondary Prevention After Coronary Bypass Surgery
Official Title
Secondary Prevention After Coronary Bypass Surgery: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Kramer, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite immediate symptomatic success after coronary bypass surgery in patients with coronary artery disease, this effect is not sustained over time since risk factors for coronary artery disease are still in place. The role of secondary prevention becomes increasingly important as it can potentially decrease or eliminate the need for another intervention in these high risk subjects. This project seeks to evaluate the effect of emphasizing secondary prevention measures in this patient population during hospital admission and through six months post-discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, CABG
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Standard care
Arm Title
2
Arm Type
Experimental
Arm Description
Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Educational session with pharmacist, nutritionist, and cardiac rehabilitation nurse
Primary Outcome Measure Information:
Title
compliance with medications and lifestyle changes
Time Frame
Month 1, 3, 6 and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects over the age of 18 who will undergo a CABG procedure and who have given written informed consent
Exclusion Criteria:
Subjects under the age of 18 or who are unable to give consent on their own behald
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kramer, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Secondary Prevention After Coronary Bypass Surgery
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