Back to resultsThe Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention (EFECTOR)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring PCI, stent, training, endothelial function, restenosis, late luminal loss, heart rate variability, oxygen uptake capacity, inflammatory markers
Eligibility Criteria
Inclusion Criteria:
- Successful PCI with stent implantation,
- Able to participate in the training program,
- No planned further revascularisation
Exclusion Criteria:
- CAGB,
- Inflammatory diseases other than CAD,
- Heart failure,
- Severe kidney failure,
- Inability to participate in the training program
Sites / Locations
- Stavanger University Hospital
Outcomes
Primary Outcome Measures
flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN
Secondary Outcome Measures
Oxygen uptake capacity (mg/kg/min), Sf36 scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469950
Brief Title
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
Acronym
EFECTOR
Official Title
Effect of Exercise Training After Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.
Detailed Description
Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
PCI, stent, training, endothelial function, restenosis, late luminal loss, heart rate variability, oxygen uptake capacity, inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
Exercise training in groups
Primary Outcome Measure Information:
Title
flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Oxygen uptake capacity (mg/kg/min), Sf36 scores
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful PCI with stent implantation,
Able to participate in the training program,
No planned further revascularisation
Exclusion Criteria:
CAGB,
Inflammatory diseases other than CAD,
Heart failure,
Severe kidney failure,
Inability to participate in the training program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Munk, MD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4022
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21450602
Citation
Munk PS, Breland UM, Aukrust P, Ueland T, Kvaloy JT, Larsen AI. High intensity interval training reduces systemic inflammation in post-PCI patients. Eur J Cardiovasc Prev Rehabil. 2011 Dec;18(6):850-7. doi: 10.1177/1741826710397600. Epub 2011 Feb 18.
Results Reference
derived
PubMed Identifier
19853690
Citation
Munk PS, Staal EM, Butt N, Isaksen K, Larsen AI. High-intensity interval training may reduce in-stent restenosis following percutaneous coronary intervention with stent implantation A randomized controlled trial evaluating the relationship to endothelial function and inflammation. Am Heart J. 2009 Nov;158(5):734-41. doi: 10.1016/j.ahj.2009.08.021.
Results Reference
derived
Learn more about this trial
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
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