Clinical trial NCT01087385: Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease
Official title: Troponin T as Risk Stratification Tool in Patients With Peripheral Arterial Occlusive Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Occlusive Disease
Keywords: peripheral arterial occlusive disease
mortality
cardiovascular events
amputation
peripheral arterial revascularization
Lead sponsor: University Heart Center Freiburg - Bad Krozingen
Sponsor class: OTHER
Collaborators: name: Johann Wolfgang Goethe University Hospital
First posted: 2010-03-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with peripheral arterial occlusive disease (Fontaine stages II-IV)

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

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.

Eligibility 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

Primary outcomes:
measure: Death
timeFrame: 1 year
Secondary outcomes:
measure: Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization
timeFrame: 1 year
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Angiologie, Herzzentrum Bad Krozingen
Study officials:
affiliation: Heart Center Bad Krozingen, Germany
name: Birgit Linnemann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.