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

PREvention of Stent Thrombosis by an Interdisciplinary Global

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• patients presenting with stent thrombosis

Exclusion Criteria:

• patients refusing informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 17, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: stent thrombosis; intra coronary imaging; blood platelet function testing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: PRESTIGE 5.0 26.01.11