Severe CardiomyopathyNCT01617863
Hemodynamics During the Soccer Championship 2012
An observational study of Severe Cardiomyopathy and Angina, Unstable, run by University Hospital Schleswig-Holstein at 4 sites in Germany.
Trial summary
The purpose of this study is to determine in soccer fans whether and to which extend positive or negative emotions during the European soccer Championship affects Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Cardiomyopathy, Angina, Unstable, Myocardial Infarction
- How many people
- 180 participants
- Where
- 4 sitesGermany
- Study dates
- Jun 2012to Jul 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic, clinical employees, students
Who may be able to join
- Best fit:
- cardiomyopathy "severe myocardial disease leading to heart failure"
- Angina, stable for at least 7 days
- Myocardial infarction during 4 weeks before inclusion, actually stable condition
- Angina, Stable, CCS II-IV
Who cannot join
- not interested in soccer championship
- age <18y
- dementia
- atrial tachycardia
- drug/alcohol abuse
- chronic kidney disease, stage 5
- pulmonary/tricuspid valve insufficiency/stenoses
- non compliant
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Universitätsklinikum Eppendorf
Hamburg, Free and Hanseatic City of Hamburg
UKSH-Lübeck
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion During the European Soccer Championship 2012
The purpose of this study is to determine in soccer fans whether and to which extend positive or negative emotions during the European soccer Championship affects Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion.
- Medical subject headings
- Cardiomyopathies, Angina, Unstable, Myocardial Infarction, Angina, Stable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe CardiomyopathyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany, Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, PD. Dr. med Michael Reppel, University Hospital Schleswig-Holstein
- Investigators
- Michael Reppel, PD. Dr. med, Study director, UKSH- Lübeck Medizinische Klinik 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617863
- Sponsor's protocol ID
- HL-Med2-EM-2012
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion During the European Soccer Championship 2012
- ClinicalTrials.gov ID
- NCT01617863
- Acronym / sponsor ID
- HL-Med2-EM-2012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Universitätsklinikum Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany, Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jun 2012 (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 in soccer fans whether and to which extend positive or negative emotions during the European soccer Championship affects Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, clinical employees, students
Key inclusion criteria (5 listed)
- cardiomyopathy "severe myocardial disease leading to heart failure"
- Angina, stable for at least 7 days
- Myocardial infarction during 4 weeks before inclusion, actually stable condition
- Angina, Stable, CCS II-IV
Key exclusion criteria (8 listed)
- not interested in soccer championship
- age <18y
- dementia
- atrial tachycardia
- drug/alcohol abuse
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 3 Jul 2012.
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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.
Michael Reppel, PD. Dr. med study director
UKSH- Lübeck Medizinische Klinik 2
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Cardiomyopathy and Angina, Unstable, run by University Hospital Schleswig-Holstein at 4 sites 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 8 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 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 Jul 2012.