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Clinical Trials/NCT00469950
NCT00469950
Completed
Phase 4

Effect of Exercise Training After Percutaneous Coronary Intervention

Helse Stavanger HF1 site in 1 country40 target enrollmentJanuary 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Helse Stavanger HF
Enrollment
40
Locations
1
Primary Endpoint
flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN
Status
Completed
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
February 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Successful PCI with stent implantation,
  • Able to participate in the training program,
  • No planned further revascularisation

Exclusion Criteria

  • Inflammatory diseases other than CAD,
  • Heart failure,
  • Severe kidney failure,
  • Inability to participate in the training program

Outcomes

Primary Outcomes

flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN

Time Frame: 6 months

Secondary Outcomes

  • Oxygen uptake capacity (mg/kg/min), Sf36 scores(6 months)

Study Sites (1)

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