Coronary Artery DiseaseNCT01228201
Physical Exercise and Coronary Artery Plaque Composition
A study testing Moderate continuous training and Aerobic interval training in people with Coronary Artery Disease, run by Trondheim University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Moderate continuous training and Aerobic interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Jul 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
- informed patient consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Moderate continuous training, Aerobic interval training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate continuous trainingBehavioural
Three training sessions per week in a total of 12 weeks
Aerobic interval trainingBehavioural
Three training sessions per week in a total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aerboic interval training | Experimental | Not described Receives: Behavioral: Aerobic interval training |
| Moderate continuous training | Active comparator | Not described Receives: Behavioral: Moderate continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artery plaque composition evaluated by intravascular ultrasound and virtual histology
Findings at 12 weeks will be compared to baseline results
Measured: After 12 weeks
Secondary outcomes (1)
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
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trondheim University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Rune Wiseth, Trondheim University Hospital
- Investigators
- Rune Wiseth, M.D, PhD, Principal investigator, Department of Cardiology, Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228201
- Sponsor's protocol ID
- NTNU - project no 46028000
- Status last verified
- Apr 2013
- First submitted
- 21 Oct 2010
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19853690Taraldsen MD, Wiseth R, Videm V, Bye A, Madssen E. Associations between circulating microRNAs and coronary plaque characteristics: potential impact from physical exercise. Physiol Genomics. 2022 Apr 1;54(4):129-140. doi: 10.1152/physiolgenomics.00071.2021. Epub 2022 Feb 28.
PubMed 35226566
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Coronary Artery Plaque Composition
- ClinicalTrials.gov ID
- NCT01228201
- Acronym / sponsor ID
- NTNU - project no 46028000
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Trondheim University HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Oct 2010 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerboic interval training | Experimental | Behavioral: Aerobic interval training |
| Moderate continuous training | Active comparator | Behavioral: Moderate continuous training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
- informed patient consent
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Moderate continuous trainingThree training sessions per week in a total of 12 weeks | Behavioural | Moderate continuous training |
| Aerobic interval trainingThree training sessions per week in a total of 12 weeks | Behavioural | Aerboic interval training |
Primary outcome
Artery plaque composition evaluated by intravascular ultrasound and virtual histology
Time frame: After 12 weeks
Findings at 12 weeks will be compared to baseline results
1 secondary outcome
Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery
Time frame: After 12 weeks
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 11 Apr 2013.
- Background: PubMed 19853690Munk 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.
- Derived from this study: PubMed 35226566Taraldsen MD, Wiseth R, Videm V, Bye A, Madssen E. Associations between circulating microRNAs and coronary plaque characteristics: potential impact from physical exercise. Physiol Genomics. 2022 Apr 1;54(4):129-140. doi: 10.1152/physiolgenomics.00071.2021. Epub 2022 Feb 28.
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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, M.D, PhD principal investigator
Department of Cardiology, Trondheim University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate continuous training and Aerobic interval training in people with Coronary Artery Disease, run by Trondheim University Hospital 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 2 inclusion and 5 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 11 Apr 2013. 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?
Artery plaque composition evaluated by intravascular ultrasound and virtual histology (time frame: After 12 weeks). 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 NCT01228201, which also lists 2 linked publications.
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 11 Apr 2013.