Coronary DiseaseCENITNCT02494947
Coronary Disease and the Effect of High-intensity Interval Training
A study testing high intensity interval-based aerobic exercise in people with Coronary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- high intensity interval-based aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- earlier bypass surgery
- known inflammatory disease other than atherosclerosis
- planned surgery within 4 months
- included in another randomized controlled study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
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.
- Conditions
- Coronary Disease
- Being tested
- high intensity interval-based aerobic exercise, Usual care
- Keywords
- Coronary Angiography, Exercise
- Medical subject headings
- Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity interval-based aerobic exerciseBehavioural
Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| interval training | Experimental | high intensity interval-based aerobic exercise Receives: Behavioral: high intensity interval-based aerobic exercise; Other: Usual care |
| controls | Other | usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid content of atherosclerotic coronary artery plaques
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Rune Wiseth, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494947
- Sponsor's protocol ID
- 2015/210
- Acronym
- CENIT
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2015
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35574968
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
- ClinicalTrials.gov ID
- NCT02494947
- Acronym / sponsor ID
- CENIT / 2015/210
- Conditions
- Coronary Disease
- Keywords
- Coronary Angiography, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interval training | Experimental | Behavioral: high intensity interval-based aerobic exercise, Other: Usual carehigh intensity interval-based aerobic exercise |
| controls | Other | Other: Usual careusual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- earlier bypass surgery
- known inflammatory disease other than atherosclerosis
- planned surgery within 4 months
- included in another randomized controlled study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity interval-based aerobic exerciseInterval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging. | Behavioural | interval training |
| Usual care | Other | controls, interval training |
Primary outcome
lipid content of atherosclerotic coronary artery plaques
Time frame: 6 months
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Derived from this study: PubMed 35574968Vesterbekkmo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Wiseth, phd prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity interval-based aerobic exercise in people with Coronary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid content of atherosclerotic coronary artery plaques (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.