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Completed

NCT Number: NCT01228201

Physical Exercise and Coronary Artery Plaque Composition

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology

Trondheim, N-7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate continuous Training

Behavioral

Three training sessions per week in a total of 12 weeks

Aerobic Interval training

Behavioral

Three training sessions per week in a total of 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Trondheim University Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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