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
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: 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 July 26, 2014