Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01087385

Enrollment

1000

Registered

2010-03-16

Start date

2010-03-31

Completion date

2011-12-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Occlusive Disease

Keywords

peripheral arterial occlusive disease, mortality, cardiovascular events, amputation, peripheral arterial revascularization

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Death	1 year

Secondary

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

Countries

Germany

Outcome results