Issue 5

Jan 11, 2017

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Issue 5

Posted in : Non classé on by : biostemi trial

Dear BIOSTEMI Investigators and Study Teams,

 We are pleased to introduce you to the 5th issue of the BIOSTEMI Study Newsletter.

From 26 April 2016, 10 study sites have been initiated and are currently actively enrolling patients in the BIOSTEMI trial. We have already randomized a total of 447 SUBJECTS (35.8% of the overall recruitment plan).

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STUDY CENTERS

 At present, 10 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

To date, a total of 447 patients have been enrolled in the BIOSTEMI trial from April 26, 2016.79 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:

– Bern, Inselspital, Prof. med. T. Pilgrim and his study team: 17 patients.

– Geneva, HUG, Prof. med. M. Roffi and his study team: 16 patients.

– Zurich, Stadtspital Triemli, Dr. med. D.J. Kurz and his study team: 15 patients.

 

 

BIOSTEMI WEBSITE

We would like to remind you of the BIOSTEMI trial website. 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.

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).

CARDIOBASE

Unscheduled visits are the most difficult to enter in Cardiobase (see pages 28 and onwards in the manual), but in case of a revascularisation (re-PCI or CABG needed) it is also important to enter the unplanned interventions first, before you open the Event = Revascularisation.

To give an example, consider a scenario of a patient with stent thrombosis, inducing myocardial infarction, which needs re-PCI of the lesion treated at baseline:

Unscheduled Visit with Revascularisation (PCI with stenting or ballooning of lesions, CABG of lesions)

It is the most efficient and less confusing to enter the forms in this order:

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(please ignore the red error message, here a list of lesion IDs should appear)

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

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