NCT01300507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

February 18, 2011

Last Update Submit

January 17, 2013

Conditions

Keywords

stent thrombosisintra coronary imagingblood platelet function testing

Outcome Measures

Primary Outcomes (1)

  • to identify novel factors responsible for the occurence of stent thrombosis

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients presenting with stent thrombosis

You may not qualify if:

  • patients refusing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UGasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

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 Officials

  • 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
  • Adnan Kastrati, MD, PhD

    German Heart Institute, Munich, Germany

    STUDY CHAIR
  • Steffen Massberg, MD, PhD

    German Heart Institute, Munich, Germany

    STUDY CHAIR
  • 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 DIRECTOR

Central Study Contacts

Walter Desmet, MD, PhD

CONTACT

Adnan Kastrati, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. W. Desmet, KULeuven, Belgium and prof. T. Gerschlick, University Hospital Leicester, UK, University Hospitals Leuven, Belgium

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2018

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations