PRESTIGE: PREvention of Stent Thrombosis by an Interdisci... | NCT01300507

Studies
PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort

NCT01300507

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Jan 18, 2013Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Coronary Artery Stent Thrombosis

Interventions

Not provided

Countries

Belgium

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 18, 2011

First Submission Date that Met QC Criteria

Feb 18, 2011

First Posted Date

Feb 21, 2011Estimated

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

Jan 17, 2013

Last Update Posted Date

Jan 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Dr Walter Desmet, prof. dr. W. Desmet, KULeuven, Belgium and prof. T. Gerschlick, University Hospital Leicester, UK, University Hospitals Leuven, Belgium, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Name	Class
Deutsches Herzzentrum Muenchen	OTHER
European Union	OTHER

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

The PRESTIGE-registry is a joint effort at 9 European heart centers to collect data regarding patients presenting with stent thrombosis in a dedicated database. There will be extensive clinical and procedural characterization, furthermore blood platelet function testing, intracoronary imaging, DNA-sampling and analysis of thrombus aspiration will be performed.

Detailed Description

Rationale: Stent Thrombosis (ST) is a serious complication of percutaneous coronary intervention (PCI) with stent implantation. Previous studies have been hampered by small sample size, in particular regarding the number of patients with late and very late ST and patients with DES thrombosis, and by incomplete patient characterisation, particularly concerning intracoronary imaging and blood platelet function data.

Objective: to identify novel predictors and to observe clinical outcome after an episode of ST, with the use of state-of-the-art new techniques such as OCT/IVUS, platelet function testing, genetic analysis.

Study design: multicenter matched case control study

Study population:

Cases: all patients presenting with definite ST. Expected number of patients to be included: 2000

Controls: patients undergoing PCI will be matched based on the following criteria:

Expected number of patients to be matched: 2000

who underwent a PCI for the same indication
who underwent a PCI on the same date (±5 days)
who underwent a PCI in the same interventional centre Main study parameters/endpoints: clinical, ECG, biochemical, angiographic, procedural, haematological, histopathological, genetic, OCT/IVUS-imaging, and follow-up characteristics Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Prior to PCI, 50 ml of whole blood will be drawn from all patients. Primary PCI for ST will be performed according to institutional best practise. During PCI, performance of Optical Coherence Tomography and/or Intravascular Ultrasound is encouraged. Thrombus aspiration is performed when indicated. During hospitalisation, all patients will be asked to fulfil a questionnaire regarding possible triggering mechanisms that might have provoked the ST. Patients will be asked to visit the patient clinic for platelet function 30 days after the acute phase of the ST. Finally, patients will be contacted for follow-up details.

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

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to identify novel factors responsible for the occurence of stent thrombosis		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients presenting with stent thrombosis

Exclusion Criteria:

patients refusing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cases: all patients presenting with definite ST. Expected number of patients to be included: 2000

Controls: patients undergoing PCI will be matched based on the following criteria:

Expected number of patients to be matched: 2000

who underwent a PCI for the same indication
who underwent a PCI on the same date (±5 days)
who underwent a PCI in the same interventional centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Walter Desmet, MD, PhD	Contact	+32 16 34 24 66		sic@uzleuven.be
Adnan Kastrati, MD, PhD	Contact	+49 (0) 89 1218-4073		Kastrati@dhm.mhn.de

Overall Officials

Name	Affiliation	Role
Walter Desmet, MD, PhD	Dept. of Cardiology, University Hospitals Leuven, Belgium	Principal Investigator
Tony Gershlick, MD, PhD	Div. of Cardiology, Glenfield Hospital, Leicester, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UGasthuisberg	Recruiting	Leuven	Flemish Brabant	3000	Belgium

Description

Biospecimen: 1, thrombusaspiration from coronary arteries, storage and analysis at the German Heart Center Munich; 2, DNA-samples: storage at German Heart Center Munich, Antonius Hospital Nieuwegein, The Netherlands, University Hospitals Leuven Belgium and University Hospital Leicester, UK