Physical Exercise and Coronary Artery Plaque Composition

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Rune Wiseth, Trondheim University Hospital
ClinicalTrials.gov Identifier:
NCT01228201
First received: October 21, 2010
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention
Coronary Artery Disease
Behavioral: Moderate continuous training
Behavioral: Aerobic interval training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Exercise and Coronary Artery Plaque Composition

Resource links provided by NLM:


Further study details as provided by Trondheim University Hospital:

Primary Outcome Measures:
  • Artery plaque composition evaluated by intravascular ultrasound and virtual histology [ Time Frame: After 12 weeks ] [ Designated as safety issue: Yes ]
    Findings at 12 weeks will be compared to baseline results


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Findings at 12 weeks will be compared to baseline results


Estimated Enrollment: 40
Study Start Date: November 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: October 21, 2010
Last Updated: April 10, 2013
Health Authority: Norway: Ethics Committee

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 April 17, 2014