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Clinical Trials/NCT00652015
NCT00652015WithdrawnNot Applicable

Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?

RWTH Aachen University1 site in 1 countryStarted: May 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively.

Study Overview

Brief Summary

In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.

Detailed Description

In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared.

The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients having developed an SAT or LT after stent implantation using PTCA

Exclusion Criteria

  • instabel coronary heart diseases,
  • systemic autoimmune diseases,
  • rheumatic diseases,
  • impaired kidney or liver function,
  • surgery within the last 3 months,
  • pregnant or lactating women

Outcomes

Primary Outcomes

The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively.

Time Frame: may 08 to may 2010

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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