WP 10: Ultrasound Study

Objectives

The main objective is to evaluate the beneficial effects of hypothermia in ameliorating reperfusion damage after delayed arterial recanalization in patients with acute ischemic stroke. The five centres participating in the substudy will use Transcranial Color-Coded-Sonography (TCCS) for the real-time diagnosis of occlusion and recanalization at different time-points after stroke onset.

The ultrasound WP, through its different tasks, aims to develop an educational program and therefore will optimize the flow of knowledge and cooperation among European countries.

The Ultrasound objectives are:

  1. TCCS protocols standardizations and development of a training program of TCCS among participant centres aimed to improve the accuracy on TCCS monitoring of occlusion and recanalization on TCD.
  2. Application of TCCS protocol in participant centres, with the aim to determine the presence and location of arterial occlusion on admission before randomization and to establish the timing of arterial recanalization during the first 24 hours
  3. Evaluation of the role of hypothermia to ameliorate reperfusion damage after early and delayed arterial recanalization. To explore whether hypothermia is associated with a better clinical course, lower risk of SICH and improved long-term clinical outcome in patients who experience delayed recanalization.
  4. TCCS data acquisition and storage. To create robust evidence, all exams will be systematically storage and submitted to a central reading panel for further evaluation in a blinded manner.
  5. Establish an independent external TCCS reading panel to optimized the accuracy of the diagnosis of occlusion and recanalization on TCCS in the trial.

Workpackage Description

The ultrasound WP is led by Carlos Molina (from ICS-HUVH) together with an expert committee will have the full responsibility to elaborate a standard TCCS substudy protocol to be used for all participant centres (Task 1), development of a TCCS training program and certification of participant centres (Task 2), ensure and monitor the adequate TCCS protocol application (Task3), standardize data acquisition, storage and delivery for central reading and analysis (Task 4) and establish an independent external TCCS reading panel.

Task 1: Definition of a standard TCCS and blood sample collection protocol (M02-04) (ICS-HUVH). Detailed protocol elaboration including: centre requirements to participate in the sub-study, sub-study design, standardized criteria for occlusion, recanalization and re-occlusion, clinical inclusion/exclusion criteria for the substudy, TCCS technical approach, standardization of the time-point for clinical and TCCS assessment(baseline, 12h, 24h), ICS-HUVH will elaborate and disseminate the TCCS protocol to participant centres.

Task 2: Development and implementation of the training program (M02-08). (ICS-HUVH). Setting a 1 full-day training meetings including technical and methodological aspects of the sub-study, cases discussion, pit-falls session, tutorials and hands-on sessions Sonographers evaluation and certification. Development a web-based educational program for new certifications and re-certifications (ICS-HUVH).

Task 3: Perform the ultrasound study (M09-52). (ICS-HUVH). Serial TCCS recording will be systematically performed at baseline, 6h, 12h and 24h to determine the timing of recanalization. Delayed recanalization (> 6h) will be categorized in 6-12 hours and 12-24h. The effects of hypothermia after early and delayed recanalization on ischemic lesion growth, risk of SICH (link WP imaging), and biomarker profile (WP biomarkers) will be established HUVH will be responsible to facilitate centres initiation; ensure an adequate recruitment of patients in the sub-study, Newsletter elaboration and dissemination. The following centres are planned to be involved in the performance of the ultrasound substudy in addition to ICS-HUVH (the leading centre): DUTH, UKER, CharitÚ, SUS and HU.

Task 4: Data acquisition and storage (M02-M60). (ICS-HUVH). Standardize data acquisition including device specific settings. Storage of both Color-Coded and wave forms images for blinded central evaluation.

Task 5: Establish an independent external TCCS reading panel (M02-57). A panel of independent external TCCS readers will include 2 expert neurosonologist. The TCCS reading panel will receive and review all storage images, categorizing as complete, partial or no recanalization.

Task 6: Generate the reports associated to the progress and results of the ultrasound study, and prepare a manuscript for publication in a scientific journal (M9-59). The members of the Study Committee, led by Dr Carlos Molina will prepare quarterly, online reports describing the progress with the ultrasound study. Responsible: Dr Carlos Molina, ICS-HUVH.

Participating Partners

Charite - Universitaetsmedizin Berlin
Skane Lans Landsting
Institut Catala de la Salut
Hacettepe Universitesi
Democritus University Of Thrace

TOP