Coronary Artery DiseasePhase 2NCT00176345
Impact of Exercise Training on Endothelial Function in CAD
A Phase 2 study testing Exercise Training in people with Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
Trial summary
Bradykinin has been identified to contribute to the release of nitric oxide (NO), prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is finally promoting a vasodilatory respone. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to not given
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable CAD
- male gender
Who cannot join
- insulin-dependent diabetes mellitus
- significant valvular heart disease
- smoking
- exercise-induced myocardial ischemia
- conditions prohibiting exercise training
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, 04289
Rainer P Hambrecht, MD, ++49-341-865 ext. 1428, hamr@medizin.uni-leipzig.de
Sandra Erbs, MD, ++49-341-865 ext. 1428, Sandra.Erbs@medizin.uni-leipzig.de
About this study
Official title: Impact of Exercise Training on Bradykinin-Mediated Endothelial Function in Patients With Coronary Artery Disease
Bradykinin has been identified to contribute to the release of nitric oxide (NO), prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is finally promoting a vasodilatory respone. Regular physical exercise training results in an improvement of endothelial function in patients with CAD. These positive effects were partially attributed to an increased expression of endothelial NO synthase (eNOS) and cyclooxygenase (COX) as a result of the training intervention.
Aim of this trial is therefore to determine, whether the training-induced correction of endothelial dysfunction is also bradykinin-dependent.
Read the detailed description
A total of 20 patients with stable coronary artery disease are prospectively randomized to 4 weeks of exercise training or sedentary lifestyle.
Endothelial function of the radial artery is determined by a high-resolution A-mode ultrasound.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise Training
- Keywords
- exercise training, endothelial 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.
Exercise TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Rainer P Hambrecht, MD, Principal investigator, University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176345
- Sponsor's protocol ID
- 639/97
- Other IDs
- 157/02
- Status last verified
- Sep 2005
- First submitted
- 11 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Training on Bradykinin-Mediated Endothelial Function in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00176345
- Acronym / sponsor ID
- 639/97
- Conditions
- Coronary Artery Disease
- Keywords
- exercise training, endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2001
- First posted
- 15 Sep 2005 (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.
Bradykinin has been identified to contribute to the release of nitric oxide (NO), prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is finally promoting a vasodilatory respone. Regular physical exercise training results in an improvement of endothelial function in patients with CAD. These positive effects were partially attributed to an increased expression of endothelial NO synthase (eNOS) and cyclooxygenase (COX) as a result of the training intervention.
Aim of this trial is therefore to determine, whether the training-induced correction of endothelial dysfunction is also bradykinin-dependent.
Detailed description
A total of 20 patients with stable coronary artery disease are prospectively randomized to 4 weeks of exercise training or sedentary lifestyle.
Endothelial function of the radial artery is determined by a high-resolution A-mode ultrasound.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable CAD
- male gender
Key exclusion criteria (5 listed)
- insulin-dependent diabetes mellitus
- significant valvular heart disease
- smoking
- exercise-induced myocardial ischemia
- conditions prohibiting exercise training
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 Training | Behavioural | – |
Primary outcome
Endothelial function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Rainer P Hambrecht, MD principal investigator
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise Training in people with 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 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer P Hambrecht, MD (++49-341 865 ext. 1428, hamr@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2005.