The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention - Full Text View

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.

First Received: May 4, 2007 Last Updated: February 3, 2009 History of Changes

Sponsored by:	Stavanger University Hospital
Information provided by:	Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00469950

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 IV

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effect of Exercise Training After Percutaneous Coronary Intervention

Further study details as provided by Stavanger University Hospital:

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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469950

Locations

Norway, Rogaland
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4022

Sponsors and Collaborators

Stavanger University Hospital

Investigators

Principal Investigator:

Peter S Munk, MD

Stavanger University Hospital

More Information

No publications provided

Responsible Party:	Stavanger University Hospital, Department of Medicine ( Peter Scott Munk )
Study ID Numbers:	3.2005.1437
Study First Received:	May 4, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00469950 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Stavanger University Hospital:

PCI
stent
training
endothelial function
restenosis

late luminal loss
heart rate variability
oxygen uptake capacity
inflammatory markers

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Disease Progression
Arteriosclerosis
Ischemia
Coronary Artery Disease
Inflammation

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 06, 2009