PRESTIGE: PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort
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.
Coronary Artery Stent Thrombosis
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||PREvention of Stent Thrombosis by an Interdisciplinary Global|
- 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
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300507
|Contact: Walter Desmet, MD, PhD||+32 16 34 24 firstname.lastname@example.org|
|Contact: Adnan Kastrati, MD, PhD||+49 (0) 89 1218-4073||Kastrati@dhm.mhn.de|
|Leuven, Flemish Brabant, Belgium, 3000|
|Sub-Investigator: Tom Adriaenssens, MD|
|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|