Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

April 14, 2015 updated by: Birgit Linnemann, University Heart Center Freiburg - Bad Krozingen

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, D-79189
        • Angiologie, Herzzentrum Bad Krozingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Troponin T elevation
No troponin T elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Heart Center Freiburg - Bad Krozingen

Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Birgit Linnemann, M.D., Heart Center Bad Krozingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (ESTIMATE)

March 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-Nr. 59/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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