Heart FailureNCT01100710
Age Gender Left Ventricular Mass and Cardiac Troponin T
An observational study of Heart Failure, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Dec 2009
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents of Heidelberg and urban hinterland
Who may be able to join
- agreement, age > 18 years, men and women
Who cannot join
- measurable heart disease, any chronic or acute disease, intake of meds, hypertension, Diabetes
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg
Heidelberg, Baden-Würtemberg, 69120
About this study
Official title: Relative Contribution of Age, Gender and Left Ventricular Mass as Quantified by Cardiac Magnetic Resonance Tomography to Detectable Levels of Cardiac Troponin T in a Healthy Reference Population Aged Below 70 Years
The purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.
Read the detailed description
We sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged between 20 and 70 years. All individuals underwent cMRI including stress testing using dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings. Partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of TnThs values.
- Conditions
- Heart Failure
- Keywords
- Age Gender left ventricular mass high sensitive Troponin T
- Medical subject headings
- Heart Failure
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 volunteers | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionDec 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 Heart FailureStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Evangelos Giannitsis, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100710
- Sponsor's protocol ID
- UHD
- Status last verified
- Feb 2007
- First submitted
- 8 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Apple FS, Smith SW, Pearce LA, Ler R, Murakami MM, Benoit MO, Levy C, Dumas C, Paul JL. Use of the bioMerieux VIDAS troponin I ultra assay for the diagnosis of myocardial infarction and detection of adverse events in patients presenting with symptoms suggestive of acute coronary syndrome. Clin Chim Acta. 2008 Apr;390(1-2):72-5. doi: 10.1016/j.cca.2007.12.016. Epub 2008 Jan 11.
PubMed 18230357
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Contribution of Age, Gender and Left Ventricular Mass as Quantified by Cardiac Magnetic Resonance Tomography to Detectable Levels of Cardiac Troponin T in a Healthy Reference Population Aged Below 70 Years
- ClinicalTrials.gov ID
- NCT01100710
- Acronym / sponsor ID
- UHD
- Conditions
- Heart Failure
- Keywords
- Age Gender left ventricular mass high sensitive Troponin T
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Apr 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.
The purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.
Detailed description
We sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged between 20 and 70 years. All individuals underwent cMRI including stress testing using dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings. Partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of TnThs values.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents of Heidelberg and urban hinterland
Key inclusion criteria (1 listed)
- agreement, age > 18 years, men and women
Key exclusion criteria (1 listed)
- measurable heart disease, any chronic or acute disease, intake of meds, hypertension, Diabetes
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 9 Apr 2010.
- Background: PubMed 18230357Apple FS, Smith SW, Pearce LA, Ler R, Murakami MM, Benoit MO, Levy C, Dumas C, Paul JL. Use of the bioMerieux VIDAS troponin I ultra assay for the diagnosis of myocardial infarction and detection of adverse events in patients presenting with symptoms suggestive of acute coronary syndrome. Clin Chim Acta. 2008 Apr;390(1-2):72-5. doi: 10.1016/j.cca.2007.12.016. Epub 2008 Jan 11.
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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.
Evangelos Giannitsis, Prof. principal investigator
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 Heart Failure, run by Heidelberg University 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 1 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 9 Apr 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 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?
On the ClinicalTrials.gov record for NCT01100710, 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 9 Apr 2010.