Physical Exercise and Coronary Artery Plaque Composition

Coronary Artery Disease Clinical Trial

Official title:

Physical Exercise and Coronary Artery Plaque Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228201
• Other study ID #: NTNU - project no 46028000
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: April 10, 2013
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Trondheim University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Moderate continuous training
Three training sessions per week in a total of 12 weeks
• Aerobic interval training
Three training sessions per week in a total of 12 weeks

Locations

Country	Name	City	State
Norway	Department of Cardiology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Trondheim University Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Munk PS, Staal EM, Butt N, Isaksen K, Larsen AI. High-intensity interval training may reduce in-stent restenosis following percutaneous coronary intervention with stent implantation A randomized controlled trial evaluating the relationship to endothelial function and inflammation. Am Heart J. 2009 Nov;158(5):734-41. doi: 10.1016/j.ahj.2009.08.021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artery plaque composition evaluated by intravascular ultrasound and virtual histology	Findings at 12 weeks will be compared to baseline results	After 12 weeks	Yes
Secondary	Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery	Findings at 12 weeks will be compared to baseline results	After 12 weeks	Yes