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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014