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

This study has been completed.
Sponsor:
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00469950
First received: May 4, 2007
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Coronary Artery Disease
Behavioral: exercise training
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Exercise Training After Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oxygen uptake capacity (mg/kg/min), Sf36 scores [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise training
    Exercise training in groups
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Helse Stavanger HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Scott Munk, Stavanger University Hospital, Department of Medicine
ClinicalTrials.gov Identifier: NCT00469950     History of Changes
Other Study ID Numbers: 3.2005.1437
Study First Received: May 4, 2007
Last Updated: February 3, 2009
Health Authority: Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on July 24, 2014