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Trial record 1 of 1 for:    NCT01087385
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Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

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ClinicalTrials.gov Identifier: NCT01087385
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Johann Wolfgang Goethe University Hospital
Information provided by (Responsible Party):
Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen

Brief Summary:
Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD).

Condition or disease
Peripheral Arterial Occlusive Disease

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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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Group/Cohort
Troponin T elevation
No troponin T elevation



Primary Outcome Measures :
  1. Death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with peripheral arterial occlusive disease (Fontaine stages II-IV)
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087385


Locations
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Germany
Angiologie, Herzzentrum Bad Krozingen
Bad Krozingen, Germany, D-79189
Sponsors and Collaborators
University Heart Center Freiburg - Bad Krozingen
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Birgit Linnemann, M.D. Heart Center Bad Krozingen, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Birgit Linnemann, Dr. Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen
ClinicalTrials.gov Identifier: NCT01087385    
Other Study ID Numbers: EK-Nr. 59/10
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen:
peripheral arterial occlusive disease
mortality
cardiovascular events
amputation
peripheral arterial revascularization
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases