Molecular and Cellular Mechanisms of the In-stent-thrombosis

Patients With SAT or LT After Stent Implantation (PCI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00652015
• Other study ID #: EK 039/08
• Status: Withdrawn
• Phase: N/A
• First received: March 31, 2008
• Last updated: September 22, 2015
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients With SAT or LT After Stent Implantation (PCI)
• Thrombosis

Locations

Country	Name	City	State
Germany	RWTH University Hospital	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		may 08 to may 2010	No