Project Overview

Carotid disease accounts for 10% of ischemic strokes and has high rate of recurrence of up to 30%-50%(1, 2). There is lack of adequate updated data on its prevalence, recurrence rates and treatment options. This is especially true for newly identified disease mechanisms like carotid web and low grade stenosis(3, 4). There is a need to understand these carotid diseases to formulate an optimal management plan. The pandemic has encouraged use of digital technology, collaboration and use of patient centered approach that will improve access, reduce patient burden and increase delivery of participants. Patient enrolment into trials has become increasingly challenging as clinical trials have grown in complexity. Both patients and physicians may lack familiarity with nuances of such trials. To bridge this gap, the goal should be to bring the trial to the patient and to involve patients in their care in every step of the way. One such potential solution is a modern e-data linked adaptive platform trial. To design and execute such a platform, we need to understand better the issues and challenges we may encounter. We therefore propose a mixed methods study involving patients which will generate research questions that are important to patients, incorporate study designs that minimise patient burden and harness the use of digital technology to build a novel platform trial focussed to answer questions around carotid diseases. Responses from this study will then be used to run a pilot study to assess viability of this approach. The ultimate aim of the study would be to develop a master protocol for a platform trial that is informed by persons with lived experience with carotid disease and by physicians who treat such patients. Such a trial will then provide high quality evidence to optimise management of carotid disease states.

Principal Investigator

Nishita Singh , University of Manitoba

Partners and Donors

Canadian Stroke Consortium

Heart and Stroke Foundation of Canada