Issue 4

Dec 13, 2016

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Issue 4

Posted in : Newsletter on by : biostemi trial

Dear BIOSTEMI Investigators and Study Teams,

We are pleased to introduce you to the 4th issue of the BIOSTEMI Study Newsletter.

To date, 10 study sites have been initiated and are currently actively enrolling patients. We have already randomized a total of 389 SUBJECTS.

During the last month, the first patient was randomized at Luzern, Kantonsspital on November 15 2016. We would like to congratulate Dr. med. F. Cuculi 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 sites are currently 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 389 patients have been enrolled in the BIOSTEMI trial. 72 additional patients have been randomized during the last month. Please find hereafter the latest enrolment chart.

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We would like to congratulate the TOP 3 enrolling centers for the last month:

– Lausanne, CHUV, Dr med. J. F. Iglesias and his study team: 19 patients.
– Zurich, Stadtspital Triemli, Dr. med. D.J. Kurz and his study team: 13 patients.
– Bern, Inselspital, Prof. med. T. Pilgrim and his study team: 11 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 would like 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
Please find in attachment the latest update of IMPORTANT CHANGES in Cardiobase v2. Most problems have now been solved, also because of your responses to improve the data capture and to eradicate the last bugs in the system.

The Cardiobase team would like to express their sincerest thanks and appreciation. Please post all your requests to: cardiobase@ctu.unibe.ch (as usual, you can ask Anja Thoms, anja.thoms@insel.ch, for support concerning events to-be-recorded and general questions not related to data capture but more related to clinical routines). 2mt is working hard on the last issues, mostly with the stop dates of P2Y12 inhibitors in the Follow-up Medication eCRF. We are also awaiting the final possibility to perform visit delete requests at CTU Bern (formally done by 2mt).

For your information, Magdalena Sanchez has left CTU Bern and we are currently evaluating new Central Data Monitor candidates.

We would be grateful if you could process the online data queries with expediency. You will see them marked in two locations: at login (you have xx new messages) and the blue envelope to the top right (the blue envelope is updated life, so you will see them arriving while you are logged-in).

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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