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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborators:
German Heart Center Munich
European Union
Information provided by (Responsible Party):
Prof Dr Walter Desmet, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01300507
First received: February 18, 2011
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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
Coronary Artery Stent Thrombosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: PREvention of Stent Thrombosis by an Interdisciplinary Global

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • to identify novel factors responsible for the occurence of stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 2000
Study Start Date: June 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Genders Eligible for Study:   Both
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
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: NCT01300507

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
German Heart Center Munich
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

No publications provided

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
Study First Received: February 18, 2011
Last Updated: January 17, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
stent thrombosis
intra coronary imaging
blood platelet function testing

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014