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Updated: Dec 6, 2025
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
In-Silico Trials for Treatment of Acute Ischemic Stroke
Praneeta R Konduri1,2, Henk A Marquering1,2, Ed E van Bavel1
1Biomedical Engineering and Physics, Amsterdam University Medical Centers, Amsterdam, Netherlands.
Abstract:
Despite improved treatment, a large portion of patients with acute ischemic stroke due to a large vessel occlusion have poor functional outcome. Further research exploring novel treatments and better patient selection has therefore been initiated. The feasibility of new treatments and optimized patient selection are commonly tested in extensive and expensive randomized clinical trials. in-silico trials, computer-based simulation of randomized clinical trials, have been proposed to aid clinical trials. In this white paper, we present our vision and approach to set up in-silico trials focusing on treatment and selection of patients with an acute ischemic stroke. The INSIST project (IN-Silico trials for treatment of acute Ischemic STroke, www.insist-h2020.eu) is a collaboration of multiple experts in computational science, cardiovascular biology, biophysics, biomedical engineering, epidemiology, radiology, and neurology. INSIST will generate virtual populations of acute ischemic stroke patients based on anonymized data from the recent stroke trials and registry, and build on the existing and emerging in-silico models for acute ischemic stroke, its treatment (thrombolysis and thrombectomy) and the resulting perfusion changes. These models will be used to design a platform for in-silico trials that will be validated with existing data and be used to provide a proof of concept of the potential efficacy of this emerging technology. The platform will be used for preliminary evaluation of the potential suitability and safety of medication, new thrombectomy device configurations and methods to select patient subpopulations for better treatment outcome. This could allow generating, exploring and refining relavant hypotheses on potential causal pathways (which may follow from the evidence obtained from clinical trials) and improving clinical trial design. Importantly, the findings of the in-silico trials will require validation under the controlled settings of randomized clinical trials.
Insights
In-silico trials simulate clinical trials for acute ischemic stroke, improving patient selection and treatment strategies. This approach aids in developing new therapies and optimizing outcomes for stroke patients.
Area of Science:
- Biomedical Engineering
- Computational Science
- Neurology
Background:
- Acute ischemic stroke from large vessel occlusion often results in poor functional outcomes despite current treatments.
- Randomized clinical trials are essential but costly and time-consuming for evaluating new stroke treatments and patient selection methods.
Purpose of the Study:
- To present a vision and approach for establishing in-silico trials for acute ischemic stroke treatment and patient selection.
- To leverage computational modeling and virtual patient populations to accelerate research and improve clinical trial design.
Main Methods:
- The INSIST project utilizes anonymized data from stroke trials to create virtual patient populations.
- Development of in-silico models for acute ischemic stroke, thrombolysis, thrombectomy, and perfusion changes.
- Creation of a validated platform for in-silico trials to evaluate treatment efficacy and safety.
Main Results:
- The INSIST platform will enable preliminary evaluation of medications, thrombectomy devices, and patient selection methods.
- In-silico trials can generate and refine hypotheses, potentially improving clinical trial design.
- Proof-of-concept for the efficacy of in-silico trials in stroke research.
Conclusions:
- In-silico trials offer a promising approach to supplement traditional clinical trials for acute ischemic stroke.
- This technology can optimize patient selection and treatment strategies, leading to better functional outcomes.
- Findings from in-silico trials require validation through randomized clinical trials.
