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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Coronary Artery Stent Thrombosis

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

1. who underwent a PCI for the same indication
2. who underwent a PCI on the same date (±5 days)
3. 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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	2000 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	PREvention of Stent Thrombosis by an Interdisciplinary Global
Study Start Date :	June 2011
Estimated Primary Completion Date :	March 2015
Estimated Study Completion Date :	March 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. to identify novel factors responsible for the occurence of stent thrombosis [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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

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

Criteria

Inclusion Criteria:

• patients presenting with stent thrombosis

Exclusion Criteria:

• patients refusing informed consent

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

Belgium
UGasthuisberg	Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Sub-Investigator: Tom Adriaenssens, MD

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Deutsches Herzzentrum Muenchen

European Union

Investigators

Principal Investigator:	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
Study Chair:	Adnan Kastrati, MD, PhD	German Heart Institute, Munich, Germany
Study Chair:	Steffen Massberg, MD, PhD	German Heart Institute, Munich, Germany
Study Director:	Tom Adriaenssens, MD	Dept. of Cardiology, University Hospitals Leuven, Belgium
Study Director:	Wouter van Werkum, MD, PhD	Dept. of Cardiology, St Antonius Hospital Nieuwegein, the Netherlands

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Prof Dr Walter Desmet, prof. dr. W. Desmet, KULeuven, Belgium and prof. T. Gerschlick, University Hospital Leicester, UK, University Hospitals Leuven, Belgium, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT01300507 History of Changes
Other Study ID Numbers:	PRESTIGE 5.0 26.01.11
First Posted:	February 21, 2011
Last Update Posted:	January 18, 2013
Last Verified:	January 2013

Keywords provided by Prof Dr Walter Desmet, University Hospital, Gasthuisberg:

stent thrombosis; intra coronary imaging; blood platelet function testing

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases