SmokingNCT01165515
Endostatin Serum Levels During Bicycle Stress Test
An observational study of Smoking and Cardiac Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cardiac Diseases
- How many people
- 240 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2008to Apr 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 patients, divided into sub-groups, always both genders will be tested for different conditions (smoking, age, CMP, CHD,...)
Who may be able to join
- Smoking/Non smoking
- Healthy/non healthy (if for CMP, CHD study)
- Age (depending on the group affiliation)
Who cannot join
- Suffering from grave diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endostatin Serum Levels During Bicycle Stress Test in Different Samples
Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.
Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen XVIII/endostatin is related to the enhancement of neo-vascularization and vascular permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the regional content of inflammatory cells. Furthermore, increased vascular permeability enhances lipid accumulation in the vessel walls, hence increasing foam cells.
Read more
Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling and severe heart failure compared with controls. Although angiogenesis was increased, tissue remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction hearts by endostatin neutralization.
However, several studies suggest that endostatin may locally modulate coronary collateral formation by inhibiting collateral vessel formation in patients with ischemic heart disease.
During treadmill exercise tests in healthy volunteers a significant increase in circulating endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal muscles by decreasing endostatin in the muscle tissues to increase blood flow to these metabolically active tissues. Thereby endostatin is released into the general circulation.
In summary, endostatin might be a new weapon to fight against atherosclerotic progression by inhibiting neo-vascularization of atherosclerotic plaques.
- Conditions
- Smoking, Cardiac Diseases
- Medical subject headings
- Smoking, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young females | 20 healthy females, aged between 18 and 35 years | |
| Healthy young males | 20 healthy males, aged between 18 and 35 years | |
| Healthy elderly smokers | 20 healthy smokers, aged between 45 and 75 years | |
| Healthy elderly non-smokers | 20 healthy non-smokers, aged between 45 and 75 years | |
| Healthy young female smokers | 20 healthy female smokers, aged between 18 and 35 years | |
| Healthy young male smokers | 20 healthy male smokers, aged between 18 and 35 years | |
| Healthy postmenopausal women | 20 healthy postmenopausal women | |
| Female CMP Patients | 20 female patients suffering from cardiomyopathy (ischemic or dilating) | |
| Male CMP Patients | 20 male patients suffering from cardiomyopathy (ischemic or dilating) | |
| Female CHD patients | 30 female patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after) | |
| Male CHD Patients | 30 male patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after) | |
| male athlets | 20 male athlets | |
| female athlets | 20 female athlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endostatin
baseline sample will be drawn at rest; a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)
Measured: baseline/maximum
Secondary outcomes (3)
catecholamine
baseline sample will be drawn at rest
Measured: baseline
hemodynamic parameters
heart rate and blood pressure behavior will be monitored throughout the entire bicycle stress test
Measured: baseline
catecholamine
a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionApr 2013
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 SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanette Strametz-Juranek, Medical University of Vienna
- Investigators
- Jeanette Strametz-Juranek, MD, Principal investigator, MUV, Department of Internal Medicine II, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165515
- Sponsor's protocol ID
- 220/2007
- Status last verified
- May 2014
- First submitted
- 13 Jul 2010
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sponder M, Dangl D, Kampf S, Fritzer-Szekeres M, Strametz-Juranek J. Exercise increases serum endostatin levels in female and male patients with diabetes and controls. Cardiovasc Diabetol. 2014 Jan 6;13:6. doi: 10.1186/1475-2840-13-6.
PubMed 24393402
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostatin Serum Levels During Bicycle Stress Test in Different Samples
- ClinicalTrials.gov ID
- NCT01165515
- Acronym / sponsor ID
- 220/2007
- Conditions
- Smoking, Cardiac Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Jul 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.
Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.
Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen XVIII/endostatin is related to the enhancement of neo-vascularization and vascular permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the regional content of inflammatory cells. Furthermore, increased vascular permeability enhances lipid accumulation in the vessel walls, hence increasing foam cells.
Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling and severe heart failure compared with controls. Although angiogenesis was increased, tissue remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction hearts by endostatin neutralization.
However, several studies suggest that endostatin may locally modulate coronary collateral formation by inhibiting collateral vessel formation in patients with ischemic heart disease.
During treadmill exercise tests in healthy volunteers a significant increase in circulating endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal muscles by decreasing endostatin in the muscle tissues to increase blood flow to these metabolically active tissues. Thereby endostatin is released into the general circulation.
In summary, endostatin might be a new weapon to fight against atherosclerotic progression by inhibiting neo-vascularization of atherosclerotic plaques.
Study design
- Time perspective
- Prospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Healthy young females | – | –20 healthy females, aged between 18 and 35 years |
| Healthy young males | – | –20 healthy males, aged between 18 and 35 years |
| Healthy elderly smokers | – | –20 healthy smokers, aged between 45 and 75 years |
| Healthy elderly non-smokers | – | –20 healthy non-smokers, aged between 45 and 75 years |
| Healthy young female smokers | – | –20 healthy female smokers, aged between 18 and 35 years |
| Healthy young male smokers | – | –20 healthy male smokers, aged between 18 and 35 years |
| Healthy postmenopausal women | – | –20 healthy postmenopausal women |
| Female CMP Patients | – | –20 female patients suffering from cardiomyopathy (ischemic or dilating) |
| Male CMP Patients | – | –20 male patients suffering from cardiomyopathy (ischemic or dilating) |
| Female CHD patients | – | –30 female patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after) |
| Male CHD Patients | – | –30 male patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after) |
| male athlets | – | –20 male athlets |
| female athlets | – | –20 female athlets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients, divided into sub-groups, always both genders will be tested for different conditions (smoking, age, CMP, CHD,...)
Key inclusion criteria (3 listed)
- Smoking/Non smoking
- Healthy/non healthy (if for CMP, CHD study)
- Age (depending on the group affiliation)
Key exclusion criteria (1 listed)
- Suffering from grave diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endostatin
Time frame: baseline/maximum
baseline sample will be drawn at rest; a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)
3 secondary outcomes
catecholamine
Time frame: baseline
hemodynamic parameters
Time frame: baseline
catecholamine
Time frame: day 1
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 20 May 2014.
- Results publication: PubMed 24393402Sponder M, Dangl D, Kampf S, Fritzer-Szekeres M, Strametz-Juranek J. Exercise increases serum endostatin levels in female and male patients with diabetes and controls. Cardiovasc Diabetol. 2014 Jan 6;13:6. doi: 10.1186/1475-2840-13-6.
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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.
Jeanette Strametz-Juranek, MD principal investigator
MUV, Department of Internal Medicine II, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Cardiac Diseases, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 1 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 20 May 2014. 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 Austria. 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?
Endostatin (time frame: baseline/maximum). 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 NCT01165515, 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 20 May 2014.