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Physical Exercise and Coronary Artery Plaque Composition

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ClinicalTrials.gov Identifier: NCT01228201
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Rune Wiseth, Trondheim University Hospital

Brief Summary:
The purpose of this study is to examine the effect of two different physical exercise protocols on changes in coronary artery plaque composition and development of in-stent restenosis in patients treated with percutaneous coronary intervention with stent implantation. The investigators will compare aerobic interval training and moderate continuous training. Both exercise protocols have a duration of 12 weeks. The investigators hypothesize that aerobic interval training is superior to moderate continuous training regarding effects on the composition of coronary artery plaques and a reduction in the development of in-stent restenosis.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Moderate continuous training Behavioral: Aerobic interval training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Exercise and Coronary Artery Plaque Composition
Study Start Date : November 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aerboic interval training Behavioral: Aerobic interval training
Three training sessions per week in a total of 12 weeks
Active Comparator: Moderate continuous training Behavioral: Moderate continuous training
Three training sessions per week in a total of 12 weeks



Primary Outcome Measures :
  1. Artery plaque composition evaluated by intravascular ultrasound and virtual histology [ Time Frame: After 12 weeks ]
    Findings at 12 weeks will be compared to baseline results


Secondary Outcome Measures :
  1. Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery [ Time Frame: After 12 weeks ]
    Findings at 12 weeks will be compared to baseline results



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
  • informed patient consent

Exclusion Criteria:

  • ST-elevation myocardial infarction,
  • inability to give informed consent,
  • inability to participate in regular training due to residency, work situation or comorbidity,
  • any known chronic inflammatory disease other than atherosclerosis,
  • planned surgery within the next four months

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): NCT01228201


Locations
Norway
Department of Cardiology
Trondheim, Norway, N-7006
Sponsors and Collaborators
Trondheim University Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Rune Wiseth, M.D, PhD Department of Cardiology, Trondheim University Hospital

Publications:
Responsible Party: Rune Wiseth, Professor Rune Wiseth, Trondheim University Hospital
ClinicalTrials.gov Identifier: NCT01228201     History of Changes
Other Study ID Numbers: NTNU - project no 46028000
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

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