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NCT01087385 Clinical Trial

Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

Peripheral Arterial Occlusive Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01087385
Other study ID # EK-Nr. 59/10
Secondary ID
Status Completed
Phase N/A
First received March 15, 2010
Last updated April 14, 2015
Start date March 2010
Est. completion date December 2011

Study information
Verified date April 2015
Source Heart Center Bad Krozingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Angiologie, Herzzentrum Bad Krozingen Bad Krozingen

Sponsors (2)
Lead Sponsor Collaborator
Heart Center Bad Krozingen Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death 1 year No
Secondary Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization 1 year No
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