Peripheral Arterial Occlusive DiseaseNCT01087385
Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease
An observational study of Peripheral Arterial Occlusive Disease, run by University Heart Center Freiburg - Bad Krozingen at 1 site in Germany.
Trial summary
Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Dec 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with peripheral arterial occlusive disease (Fontaine stages II-IV)
Who may be able to join
- symptomatic peripheral arterial occlusive disease
- aged >/= 18 years
Who cannot join
- unstable angina or acute coronary syndrome < 14 days
- percutaneous coronary intervention < 14 days
- other interventions or disease associated with troponin T release (i.e., acute pulmonary embolism, aortic dissection, heart valve replacement, acute heart failure, non-ischemic cardiomyopathy, heart surgery, thoracic trauma, endocarditis, myocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease
Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD).
Read the detailed description
Troponin T and I are established risk markers in patients with acute coronary syndrome. Only recently, troponin I was found to be elevated in patients with acute critical limb ischaemia. In another study, troponin I was associated with a higher mortality in patients with chronic critical limb ischaemia followed over two years. In a longitudinal study design we intend to follow all patients that were treated for symptomatic PAOD (Fontaine stages II-IV) from 01/2007 to 12/2007 in our department of angiology. Main outcome parameters are death and the occurrence of major vascular events and revascularization procedures during follow-up.
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- peripheral arterial occlusive disease, mortality, cardiovascular events, amputation, peripheral arterial revascularization
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
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 |
|---|---|---|
| Troponin T elevation | Not described | |
| No troponin T elevation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 1 year
Secondary outcomes (1)
Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Occlusive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Heart Center Freiburg - Bad Krozingen
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Principal investigator, Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen
- Investigators
- Birgit Linnemann, M.D., Principal investigator, Heart Center Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087385
- Sponsor's protocol ID
- EK-Nr. 59/10
- Status last verified
- Apr 2015
- First submitted
- 15 Mar 2010
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Linnemann B, Sutter T, Herrmann E, Sixt S, Rastan A, Schwarzwaelder U, Noory E, Buergelin K, Beschorner U, Zeller T. Elevated cardiac troponin T is associated with higher mortality and amputation rates in patients with peripheral arterial disease. J Am Coll Cardiol. 2014 Apr 22;63(15):1529-38. doi: 10.1016/j.jacc.2013.05.059. Epub 2013 Jun 21.
PubMed 23792625Linnemann B, Sutter T, Sixt S, Rastan A, Schwarzwaelder U, Noory E, Buergelin K, Beschorner U, Zeller T. Elevated cardiac troponin T contributes to prediction of worse in-hospital outcomes after endovascular therapy for acute limb ischemia. J Vasc Surg. 2012 Mar;55(3):721-9. doi: 10.1016/j.jvs.2011.10.024. Epub 2012 Jan 24.
PubMed 22277685
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT01087385
- Acronym / sponsor ID
- EK-Nr. 59/10
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- peripheral arterial occlusive disease, mortality, cardiovascular events, amputation, peripheral arterial revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Mar 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.
Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD).
Detailed description
Troponin T and I are established risk markers in patients with acute coronary syndrome. Only recently, troponin I was found to be elevated in patients with acute critical limb ischaemia. In another study, troponin I was associated with a higher mortality in patients with chronic critical limb ischaemia followed over two years. In a longitudinal study design we intend to follow all patients that were treated for symptomatic PAOD (Fontaine stages II-IV) from 01/2007 to 12/2007 in our department of angiology. Main outcome parameters are death and the occurrence of major vascular events and revascularization procedures during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Troponin T elevation | – | – |
| No troponin T elevation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with peripheral arterial occlusive disease (Fontaine stages II-IV)
Key inclusion criteria (2 listed)
- symptomatic peripheral arterial occlusive disease
- aged >/= 18 years
Key exclusion criteria (3 listed)
- unstable angina or acute coronary syndrome < 14 days
- percutaneous coronary intervention < 14 days
- other interventions or disease associated with troponin T release (i.e., acute pulmonary embolism, aortic dissection, heart valve replacement, acute heart failure, non-ischemic cardiomyopathy, heart surgery, thoracic trauma, endocarditis, myocarditis
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
Death
Time frame: 1 year
1 secondary outcome
Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization
Time frame: 1 year
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 15 Apr 2015.
- Derived from this study: PubMed 23792625Linnemann B, Sutter T, Herrmann E, Sixt S, Rastan A, Schwarzwaelder U, Noory E, Buergelin K, Beschorner U, Zeller T. Elevated cardiac troponin T is associated with higher mortality and amputation rates in patients with peripheral arterial disease. J Am Coll Cardiol. 2014 Apr 22;63(15):1529-38. doi: 10.1016/j.jacc.2013.05.059. Epub 2013 Jun 21.
- Derived from this study: PubMed 22277685Linnemann B, Sutter T, Sixt S, Rastan A, Schwarzwaelder U, Noory E, Buergelin K, Beschorner U, Zeller T. Elevated cardiac troponin T contributes to prediction of worse in-hospital outcomes after endovascular therapy for acute limb ischemia. J Vasc Surg. 2012 Mar;55(3):721-9. doi: 10.1016/j.jvs.2011.10.024. Epub 2012 Jan 24.
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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.
Birgit Linnemann, M.D. principal investigator
Heart Center Bad Krozingen, Germany
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 Peripheral Arterial Occlusive Disease, run by University Heart Center Freiburg - Bad Krozingen 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 3 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 15 Apr 2015. 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.
What does the primary outcome measure?
Death (time frame: 1 year). 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 NCT01087385, which also lists 2 linked publications.
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 Apr 2015.