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The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention (EFECTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469950
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: exercise training Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Exercise Training After Percutaneous Coronary Intervention
Study Start Date : January 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Intervention Details:
  • Behavioral: exercise training
    Exercise training in groups

Primary Outcome Measures :
  1. flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Oxygen uptake capacity (mg/kg/min), Sf36 scores [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469950

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Stavanger University Hospital
Stavanger, Rogaland, Norway, 4022
Sponsors and Collaborators
Helse Stavanger HF
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Principal Investigator: Peter S Munk, MD Helse Stavanger HF
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF Identifier: NCT00469950    
Other Study ID Numbers: 3.2005.1437
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: February 2009
Keywords provided by Helse Stavanger HF:
endothelial function
late luminal loss
heart rate variability
oxygen uptake capacity
inflammatory markers
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases