Coronary Artery DiseaseNCT00947050
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
A study testing dynamic physical exercise in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- dynamic physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2005to Mar 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than or 18 years old
- 1- to 3-vessel coronary artery disease (CAD)
- Stable angina pectoris
- At least 1 stenotic lesion suitable for PCI
- Negative Allen-test
- Written informed consent to participate in the study
Who cannot join
- Patients admitted as emergencies
- Acute myocardial infarction
- Unstable CAD
- Q-wave myocardial infarction in the area undergoing CFI measurement
- CAD treated best by CABG
- Severe valve disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.
Read the detailed description
The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance.
The purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.
- Conditions
- Coronary Artery Disease
- Being tested
- dynamic physical exercise
- Keywords
- CAD, prompt physical exercise, collateral function
- 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.
dynamic physical exerciseOther
Also called rest first, ex first
dynamic supine bicycle exercise for 6 minutes
| Study group | Role | What they receive |
|---|---|---|
| rest first | Active comparator | rest first, cfi, exercise, cfi Receives: Other: dynamic physical exercise |
| exercise first | Active comparator | ex first Receives: Other: dynamic physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
Measured: 6 minutes
Secondary outcomes (1)
Correlation of collateral flow index change and maximal workload.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionMar 2009
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 Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Investigators
- Steffen Gloekler, MD, Principal investigator, University of BernMario Togni, MD, Principal investigator, University of BernPascal Meier, MD, Principal investigator, University of BernChristian Seiler, MD,Prof., Study chair, University of BernStefano de Marchi, MD, Principal investigator, Univerity of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947050
- Sponsor's protocol ID
- 14/05
- Status last verified
- Oct 2010
- First submitted
- 24 Jul 2009
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Togni M, Gloekler S, Meier P, de Marchi SF, Rutz T, Steck H, Traupe T, Seiler C. Instantaneous coronary collateral function during supine bicycle exercise. Eur Heart J. 2010 Sep;31(17):2148-55. doi: 10.1093/eurheartj/ehq202. Epub 2010 Jun 28.
PubMed 20584776
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
- ClinicalTrials.gov ID
- NCT00947050
- Acronym / sponsor ID
- 14/05
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, prompt physical exercise, collateral function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jul 2009 (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 in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.
Detailed description
The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance.
The purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rest first | Active comparator | Other: dynamic physical exerciserest first, cfi, exercise, cfi |
| exercise first | Active comparator | Other: dynamic physical exerciseex first |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age more than or 18 years old
- 1- to 3-vessel coronary artery disease (CAD)
- Stable angina pectoris
- At least 1 stenotic lesion suitable for PCI
- Negative Allen-test
Key exclusion criteria (7 listed)
- Patients admitted as emergencies
- Acute myocardial infarction
- Unstable CAD
- Q-wave myocardial infarction in the area undergoing CFI measurement
- CAD treated best by CABG
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 |
|---|---|---|
| dynamic physical exerciseAlso: rest first, ex firstdynamic supine bicycle exercise for 6 minutes | Other | exercise first, rest first |
Primary outcome
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
Time frame: 6 minutes
1 secondary outcome
Correlation of collateral flow index change and maximal workload.
Time frame: 6 minutes
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 2010.
- Derived from this study: PubMed 20584776Togni M, Gloekler S, Meier P, de Marchi SF, Rutz T, Steck H, Traupe T, Seiler C. Instantaneous coronary collateral function during supine bicycle exercise. Eur Heart J. 2010 Sep;31(17):2148-55. doi: 10.1093/eurheartj/ehq202. Epub 2010 Jun 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.
Steffen Gloekler, MD principal investigator
University of Bern
Mario Togni, MD principal investigator
University of Bern
Pascal Meier, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic physical exercise in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 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 2010. 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 Switzerland. 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?
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R). (time frame: 6 minutes). 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 NCT00947050, 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 Oct 2010.