NCT01087385

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

March 15, 2010

Last Update Submit

April 14, 2015

Conditions

Keywords

peripheral arterial occlusive diseasemortalitycardiovascular eventsamputationperipheral arterial revascularization

Outcome Measures

Primary Outcomes (1)

  • Death

    1 year

Secondary Outcomes (1)

  • Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, stroke, amputation, peripheral revascularization, target limb revascularization, target vessel revascularization

    1 year

Study Arms (2)

Troponin T elevation

No troponin T elevation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • symptomatic peripheral arterial occlusive disease
  • aged \>/= 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angiologie, Herzzentrum Bad Krozingen

Bad Krozingen, D-79189, Germany

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

  • Birgit Linnemann, M.D.

    Heart Center Bad Krozingen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Birgit Linnemann

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations