Molecular and Cellular Mechanisms of the In-stent-thrombosis | NCT00652015

Studies
Molecular and Cellular Mechanisms of the In-stent-thrombosis

NCT00652015

Sponsor

RWTH Aachen University

Status

Withdrawn

Last Update Posted

Sep 23, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Patients With SAT or LT After Stent Implantation (PCI)

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment numbers could not at all been achieved in an acceptable period of time

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Apr 2, 2008

First Posted Date

Apr 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients having developed an SAT or LT after stent implantation using PTCA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burcin Özüyaman, MD	RWTH Aachen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RWTH University Hospital		Aachen		52057	Germany