Coronary Disease and the Effect of High-intensity Interval Training
CENIT
Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 26, 2019
August 1, 2019
3.2 years
July 6, 2015
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lipid content of atherosclerotic coronary artery plaques
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
6 months
Study Arms (2)
interval training
EXPERIMENTALhigh intensity interval-based aerobic exercise
controls
OTHERusual care
Interventions
Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- earlier bypass surgery
- known inflammatory disease other than atherosclerosis
- planned surgery within 4 months
- included in another randomized controlled study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olavs Hospital
Trondheim, Norway
Related Publications (1)
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.
PMID: 35574968DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rune Wiseth, phd prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 10, 2015
Study Start
February 1, 2016
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 26, 2019
Record last verified: 2019-08