Molecular and Cellular Mechanisms of the In-stent-thrombosis

This study has been withdrawn prior to enrollment.
(Recruitment numbers could not at all been achieved in an acceptable period of time)
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00652015
First received: March 31, 2008
Last updated: December 17, 2010
Last verified: December 2010
  Purpose

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


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

Study Type: Observational
Study Design: 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?

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 160
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652015

Locations
Germany
RWTH University Hospital
Aachen, Germany, 52057
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Burcin Özüyaman, MD RWTH Aachen University
  More Information

No publications provided

Responsible Party: Burcin Özüyaman, MD, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00652015     History of Changes
Other Study ID Numbers: EK 039/08
Study First Received: March 31, 2008
Last Updated: December 17, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by RWTH Aachen University:
in-stent-thrombosis
CD39
CD73
EPC

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014