Modes of Exercise and Myocardial and Endothelial FunctionMMSNCT00500773
Investigation of Cardiac Function and Cardiovascular Risk Factors in Marathon Runners- The Munich Marathon Study
An observational study of Modes of Exercise and Myocardial and Endothelial Function and Microcirculation, run by Technical University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine the cardiovascular risk involved in the exertional exercise of marathon running. The researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Modes of Exercise and Myocardial and Endothelial Function, Microcirculation, Subclinical Endorgan Damage
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to May 2008
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy male marathon runners with no more than one treated cardiovascular risk factor aged 30-60 years. Participation of at least a 1/2 marathon in recent history.
Who may be able to join
- Men aged 30-60 years
- Obese subjects: BMI > 27 and waist circumference > 102cm
Who cannot join
- manifested heart disease
- insulin dependent diabetes mellitus
- multiple drug therapy
- GFR < 60 ml/min.
- claustrophobia
- metal implants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prevention and Sportsmedicine, Technical University of Munich
Connollystrasse 32, Munich, Bavaria, 80809
About this study
Official title: Investigation of Myocardial Injury, Ventricular Dysfunction and Cardiovascular Risk Factors in Different Groups of Marathon Runners
The purpose of this study is to determine the cardiovascular risk involved in the exertional exercise of marathon running. The researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. Subclinical injuries to heart and arteries are being investigated in different groups of runners, including obese participants.
Read the detailed description
Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.
The researchers aim to define the critical role of inflammatory markers and cardiovascular risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.
The study groups are divided into average trained runners (40 km/week), average trained obese runners and highly trained runners (> 70km/week). Training programmes are supervised by professional coaches. Individual scientific marathon contests are organized for the assessments.
Diagnostic tools include measurements of pulse wave velocity and heart rate turbulence, echocardiography and, for the first time, MRI-scans pre- and post marathon running. Additionally, cardiovascular markers such as endothelial progenitor cells (EPCs)and adiponectin are measured. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor.
- Conditions
- Modes of Exercise and Myocardial and Endothelial Function, Microcirculation, Subclinical Endorgan Damage, Obesity
- Keywords
- cardiovascular risc factors, inflammation, aerobic and exertional exercise
- Medical subject headings
- Obesity, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modes of Exercise and Myocardial and Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Investigators
- Henner Hanssen, MD, Principal investigator, Department of Prevention and Sportmedicine, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500773
- Sponsor's protocol ID
- 1807/07
- Acronym
- MMS
- Status last verified
- Apr 2014
- First submitted
- 11 Jul 2007
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Myocardial Injury, Ventricular Dysfunction and Cardiovascular Risk Factors in Different Groups of Marathon Runners
- ClinicalTrials.gov ID
- NCT00500773
- Acronym / sponsor ID
- MMS / 1807/07
- Conditions
- Modes of Exercise and Myocardial and Endothelial Function, Microcirculation, Subclinical Endorgan Damage, Obesity
- Keywords
- cardiovascular risc factors, inflammation, aerobic and exertional exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Jul 2007 (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 determine the cardiovascular risk involved in the exertional exercise of marathon running. The researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. Subclinical injuries to heart and arteries are being investigated in different groups of runners, including obese participants.
Detailed description
Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.
The researchers aim to define the critical role of inflammatory markers and cardiovascular risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.
The study groups are divided into average trained runners (40 km/week), average trained obese runners and highly trained runners (> 70km/week). Training programmes are supervised by professional coaches. Individual scientific marathon contests are organized for the assessments.
Diagnostic tools include measurements of pulse wave velocity and heart rate turbulence, echocardiography and, for the first time, MRI-scans pre- and post marathon running. Additionally, cardiovascular markers such as endothelial progenitor cells (EPCs)and adiponectin are measured. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male marathon runners with no more than one treated cardiovascular risk factor aged 30-60 years. Participation of at least a 1/2 marathon in recent history.
Key inclusion criteria (2 listed)
- Men aged 30-60 years
- Obese subjects: BMI > 27 and waist circumference > 102cm
Key exclusion criteria (6 listed)
- manifested heart disease
- insulin dependent diabetes mellitus
- multiple drug therapy
- GFR < 60 ml/min.
- claustrophobia
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
Not reported in the source record.
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 1 May 2014.
- Institutional homepageLink provided by the sponsor.
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.
Henner Hanssen, MD principal investigator
Department of Prevention and Sportmedicine, Technical University Munich
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 Modes of Exercise and Myocardial and Endothelial Function and Microcirculation, run by Technical University of Munich 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 6 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 1 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 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.
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 1 May 2014.