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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)

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ClinicalTrials.gov Identifier: NCT00469950
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : April 14, 2015
Sponsor:
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).

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00469950


Locations
Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4022
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Peter S Munk, MD Helse Stavanger HF

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00469950     History of Changes
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:
PCI
stent
training
endothelial function
restenosis
late luminal loss
heart rate variability
oxygen uptake capacity
inflammatory markers

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