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CompletedNCT01087385Updated Apr 15, 2015

Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

An observational study in Peripheral Arterial Occlusive Disease, sponsored by University Heart Center Freiburg - Bad Krozingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by University Heart Center Freiburg - Bad Krozingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Peripheral Arterial Occlusive Disease

Keywords

  • peripheral arterial occlusive disease
  • mortality
  • cardiovascular events
  • amputation
  • peripheral arterial revascularization
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In context

Arterial Occlusive Diseases

296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.

This study's enrollment of 1,000 is above the median of 183 across 75 observational studies indexed under Arterial Occlusive Diseases.

Browse Arterial Occlusive Diseases studies →

Lead sponsor

University Heart Center Freiburg - Bad Krozingen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with peripheral arterial occlusive disease (Fontaine stages II-IV)

Inclusion criteria

  • symptomatic peripheral arterial occlusive disease
  • aged >/= 18 years

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (actual)

Groups and cohorts

  • Troponin T elevation
  • No troponin T elevation
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What researchers measure

Primary outcomes

  1. Death

    Time frame: 1 year

Secondary outcomes

  1. Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization

    Time frame: 1 year

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Study locations

1 site
  • Angiologie, Herzzentrum Bad Krozingen
    Bad Krozingen, D-79189, Germany
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References and documents

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 23792625 ↗
  • Linnemann 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01087385
Lead sponsor
University Heart Center Freiburg - Bad Krozingen
Collaborators
Johann Wolfgang Goethe University Hospital
Responsible party
Birgit Linnemann (Dr. Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen) — Principal investigator
First posted
Mar 16, 2010
Start date
Mar 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 15, 2015

Study contacts

Birgit Linnemann, M.D.
principal investigator · Heart Center Bad Krozingen, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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