Stable Coronary Artery DiseaseNCT01209637
Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD
A study testing exercise training and Intensive exercise training in people with Stable Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
Trial summary
Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved. There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- exercise training and Intensive exercise training
- 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 siteGermany
- Study dates
- Mar 2010to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable CAD
- min.1 coronary artery stenosis >50%
- patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test
- angina threshold >75 Watt
- informed consent
Who cannot join
- Age <18 oder >75
- akut coronary syndrome within 2 weeks
- LV-EF < 40 %
- significant valve diseases
- reduced patient compliance
- muscular disorder
- bronchial asthma or COLD stadium III and IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease
Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.
There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- exercise training, Intensive exercise training
- Keywords
- stable coronary artery disease, significant coronary stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
exercise training min. 4 times a day for at least 30 min
Intensive exercise trainingBehavioural
Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | standard care of coronary artery diseases incl. recommended home based exercise 3x/week |
| Exercise training | Active comparator | exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center Receives: Behavioral: exercise training |
| intensive exercise training | Active comparator | intensive exercise training incl. interval training Receives: Behavioral: Intensive exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary collateral blod flow
Measured: 4 weeks
Secondary outcomes (3)
plaque composition within the coronary artery
plaque composition measured by virtual histology intravascular ultrasound
Measured: 4 weeks
MACCE
major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)
Measured: 4 week, 6 months, 12 months
atherosclerosis parameter within the laboratory
e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide
Measured: 4 weeks, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 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 Stable 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Sven Möbius-Winkler, MD, Principal investigator, Heart Center Leipzig- University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209637
- Sponsor's protocol ID
- SMW 04
- Status last verified
- Oct 2016
- First submitted
- 24 Sep 2010
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mobius-Winkler S, Uhlemann M, Adams V, Sandri M, Erbs S, Lenk K, Mangner N, Mueller U, Adam J, Grunze M, Brunner S, Hilberg T, Mende M, Linke AP, Schuler G. Coronary Collateral Growth Induced by Physical Exercise: Results of the Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable Coronary Artery Disease (EXCITE) Trial. Circulation. 2016 Apr 12;133(15):1438-48; discussion 1448. doi: 10.1161/CIRCULATIONAHA.115.016442. Epub 2016 Mar 15.
PubMed 26979085Uhlemann M, Adams V, Lenk K, Linke A, Erbs S, Adam J, Thiele H, Hilberg T, Gutberlet M, Grunze M, Schuler GC, Mobius-Winkler S. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial. Trials. 2012 Sep 14;13:167. doi: 10.1186/1745-6215-13-167.
PubMed 22974129
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01209637
- Acronym / sponsor ID
- SMW 04
- Conditions
- Stable Coronary Artery Disease
- Keywords
- stable coronary artery disease, significant coronary stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 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.
Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.
There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –standard care of coronary artery diseases incl. recommended home based exercise 3x/week |
| Exercise training | Active comparator | Behavioral: exercise trainingexercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center |
| intensive exercise training | Active comparator | Behavioral: Intensive exercise trainingintensive exercise training incl. interval training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stable CAD
- min.1 coronary artery stenosis >50%
- patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test
- angina threshold >75 Watt
- informed consent
Key exclusion criteria (7 listed)
- Age <18 oder >75
- akut coronary syndrome within 2 weeks
- LV-EF < 40 %
- significant valve diseases
- reduced patient compliance
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 |
|---|---|---|
| exercise trainingexercise training min. 4 times a day for at least 30 min | Behavioural | Exercise training |
| Intensive exercise trainingIntensive exercise training for 4 times / day incl. interval training at 95% individual threshold | Behavioural | intensive exercise training |
Primary outcome
coronary collateral blod flow
Time frame: 4 weeks
3 secondary outcomes
plaque composition within the coronary artery
Time frame: 4 weeks
MACCE
Time frame: 4 week, 6 months, 12 months
atherosclerosis parameter within the laboratory
Time frame: 4 weeks, 3, 6, 12 months
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 Oct 2016.
- Derived from this study: PubMed 26979085Mobius-Winkler S, Uhlemann M, Adams V, Sandri M, Erbs S, Lenk K, Mangner N, Mueller U, Adam J, Grunze M, Brunner S, Hilberg T, Mende M, Linke AP, Schuler G. Coronary Collateral Growth Induced by Physical Exercise: Results of the Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable Coronary Artery Disease (EXCITE) Trial. Circulation. 2016 Apr 12;133(15):1438-48; discussion 1448. doi: 10.1161/CIRCULATIONAHA.115.016442. Epub 2016 Mar 15.
- Derived from this study: PubMed 22974129Uhlemann M, Adams V, Lenk K, Linke A, Erbs S, Adam J, Thiele H, Hilberg T, Gutberlet M, Grunze M, Schuler GC, Mobius-Winkler S. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial. Trials. 2012 Sep 14;13:167. doi: 10.1186/1745-6215-13-167.
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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.
Sven Möbius-Winkler, MD principal investigator
Heart Center Leipzig- University Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training and Intensive exercise training in people with Stable Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
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 7 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 Oct 2016. 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 Germany. 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?
coronary collateral blod flow (time frame: 4 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 NCT01209637, 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 26 Oct 2016.