Issue 3

Nov 4, 2016

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Issue 3

Posted in : Newsletter on by : biostemi trial

STUDY NEWSLETTER
November 2016
ISSUE 3

Dear BIOSTEMI Investigators and Study Teams,

 

We are pleased to introduce you to the third issue of the BIOSTEMI Study Newsletter.

To date, a total of 10 study sites have been initiated and 9 study sites have started the screening process. We have already randomized a total of 298 subjects.

During the last month, the first patient was randomized at Basel Universitätsspital on 15 October 2016. We would like to congratulate Prof. med. Christoph Kaiser and his study team for the inclusion of the first patient at his study site!

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STUDY CENTERS

At the moment, 10 study centers have been initiated and 9 study sites are actively enrolling patients in the BIOSTEMI study. Please see here below the current list of investigators and initiated study sites.

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STUDY STATUS

A total of 298 patients have been enrolled in the BIOSTEMI trial. 99 additional patients have been randomized during the last month. Please find hereafter the latest enrolment chart.

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– Bern, Inselspital, Prof. med. T. Pilgrim and his study team: 25 patients
– Geneva, HUG, Prof. med. M. Roffi and his study team: 14 patients
– Sion, Hôpital du valais, Dr med. M. Tapponnier and his study team: 13 patients

 

SAFETY REPORTS

We would like to remind the study teams that the safety reports must be sent within 24 h to the Sponsor/Investigator of the study. Please send the form to the study coordinator Anja Thoms (anja.thoms@insel.ch) and to the coordinating investigator Prof. Thomas Pilgrim (thomas.pilgrim@insel.ch).

 

BIOSTEMI WEBSITE

We are pleased to remember you that the BIOSTEMI trial website has been recently launched. The official study webpage (www.biostemi-trial.ch) provides all information related to the BIOSTEMI trial, including a monthly updated enrolment status, official study documents and contact details.

 

CARDIOBASE UPDATE

 

We will update shortly the Cardiobase database from version 1 to version 2. As a consequence, the version 1 will SHUT down on Saturday, 5 November 2016 at midnight. The system will be blocked for a couple of hours.

PLEASE NOTE THAT YOU WILL NOT BE ABLE TO RANDOMIZE PATIENTS FROM SATURDAY 5 NOVEMBER 00:00 TO 12:00. DO NOT FORGET TO INFORM YOUR STUDY TEAMS, INCLUDING CATHETERIZATION LABORATORIES AND STUDY PERSONNEL.

Afterwards, you will find the same patients, data and functionality in version 2 compared to version 1.

Version 2 has a couple of changes compared to version 1, which you will find summarized in the attached document. Please note that version 2 is a beta-version, so inform us if some items are not working properly or if you are getting incomprehensible error messages. A snapshot or link to the eCRF with the error can be send to CTU Bern (contact details on the BIOSTEMI official study website: www.biostemi-trial.ch).

 

We would like to thank you all very much for your efforts and commitment to the BIOSTEMI study. Please do not hesitate to contact us in case of questions or concerns related to the study.

 

Yours sincerely,

 

 

 

Dr. med. Juan F. Iglesias

Lausanne University Hospital, Switzerland

E-mail: juan-fernando.iglesias@chuv.ch

 

 

Prof. med. Thomas Pilgrim

Bern University Hospital, Switzerland

E-mail: Thomas.pilgrim.insel.ch

 

 

Dr. med. Olivier Muller

Lausanne University Hospital, Switzerland

E-mail: olivier.muller@chuv.ch