Molecular and Cellular Mechanisms of the In-stent-thrombosis

NCT ID: NCT00652015

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patients With SAT or LT After Stent Implantation (PCI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients having developed an in-stent-thrombosis (40 SAT, 40 LT)

No interventions assigned to this group

2

Patients having not developed an in-stent-thrombosis after stent implantation using PTCA

No interventions assigned to this group

Eligibility Criteria

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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,
* tumors,
* impaired kidney or liver function,
* surgery within the last 3 months,
* pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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RWTH Aachen University

Principal Investigators

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Burcin Özüyaman, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

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RWTH University Hospital

Aachen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EK 039/08

Identifier Type: -

Identifier Source: org_study_id

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