Coronary Disease and the Effect of High-intensity Interval Training (CENIT)
Primary Purpose
Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
high intensity interval-based aerobic exercise
Usual care
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring Coronary Angiography, Exercise
Eligibility Criteria
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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
interval training
controls
Arm Description
high intensity interval-based aerobic exercise
usual care
Outcomes
Primary Outcome Measures
lipid content of atherosclerotic coronary artery plaques
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT02494947
First Posted
July 6, 2015
Last Updated
August 21, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02494947
Brief Title
Coronary Disease and the Effect of High-intensity Interval Training
Acronym
CENIT
Official Title
Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Angiography, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interval training
Arm Type
Experimental
Arm Description
high intensity interval-based aerobic exercise
Arm Title
controls
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
high intensity interval-based aerobic exercise
Intervention Description
Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
lipid content of atherosclerotic coronary artery plaques
Description
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35574968
Citation
Vesterbekkmo EK, Madssen E, Aamot Aksetoy IL, Follestad T, Nilsen HO, Hegbom K, Wisloff U, Wiseth R. CENIT (Impact of Cardiac Exercise Training on Lipid Content in Coronary Atheromatous Plaques Evaluated by Near-Infrared Spectroscopy): A Randomized Trial. J Am Heart Assoc. 2022 May 17;11(10):e024705. doi: 10.1161/JAHA.121.024705. Epub 2022 May 16.
Results Reference
derived
Learn more about this trial
Coronary Disease and the Effect of High-intensity Interval Training
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