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Molecular and Cellular Mechanisms of the In-stent-thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652015
Recruitment Status : Withdrawn (Recruitment numbers could not at all been achieved in an acceptable period of time)
First Posted : April 3, 2008
Last Update Posted : September 23, 2015
Sponsor:
Information provided by:
RWTH Aachen University

Study Description
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Brief Summary:
In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.

Condition or disease
Patients With SAT or LT After Stent Implantation (PCI)

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
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?
Study Start Date : May 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Groups and Cohorts
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Group/Cohort
1
Patients having developed an in-stent-thrombosis (40 SAT, 40 LT)
2
Patients having not developed an in-stent-thrombosis after stent implantation using PTCA


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA

1 sample of approximately 30 mL blood will be taken from each patient of both study group.

CD39 and CD73 activity as well as EPC-number and function will be analyzed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients having developed an SAT or LT after stent implantation using PTCA
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652015


Locations
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Germany
RWTH University Hospital
Aachen, Germany, 52057
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Burcin Özüyaman, MD RWTH Aachen University
More Information
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Responsible Party: Burcin Özüyaman, MD, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00652015    
Other Study ID Numbers: EK 039/08
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by RWTH Aachen University:
in-stent-thrombosis
CD39
CD73
EPC
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases