Coronary Disease Clinical Trial
— CENITOfficial title:
Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
NCT number | NCT02494947 |
Other study ID # | 2015/210 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | April 2019 |
Verified date | August 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to investigate if systematic, high intensity, interval-based aerobic exercise training results in regression of lipid content of atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with stable coronary heart disease. Composition and morphologic characteristics of plaques will be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - stable coronary artery disease - will undergo cardiac catheterization - will be treated with percutaneous coronary intervention (PCI) - signed written informed consent - able to execute the intervention Exclusion Criteria: - earlier bypass surgery - known inflammatory disease other than atherosclerosis - planned surgery within 4 months - included in another randomized controlled study |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lipid content of atherosclerotic coronary artery plaques | Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy | 6 months |
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