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Completed

NCT Number: NCT01087385

Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

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

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Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angiologie, Herzzentrum Bad Krozingen

Bad Krozingen, D-79189, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University Heart Center Freiburg - Bad Krozingen

Other

Collaborators

  • Johann Wolfgang Goethe University Hospital

Registry information

Official study title

Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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