Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

NCT ID: NCT01087385

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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

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Peripheral Arterial Occlusive Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Troponin T elevation

No interventions assigned to this group

No troponin T elevation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role collaborator

University Heart Center Freiburg - Bad Krozingen

OTHER

Sponsor Role lead

Responsible Party

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Birgit Linnemann

Dr. Birgit Linnemann

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgit Linnemann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Heart Center Bad Krozingen, Germany

Locations

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Angiologie, Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23792625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22277685 (View on PubMed)

Other Identifiers

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EK-Nr. 59/10

Identifier Type: -

Identifier Source: org_study_id

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