IVT vs EVT vs Bridging Therapy for AIS
Research type
Research Study
Full title
Acute Ischemic Stroke: Long Term Cognitive and Psycho-social Outcomes following Bridging-Therapy versus Direct Endovascular Thrombectomy versus Intravenous Thrombolysis
IRAS ID
302363
Contact name
Colin Wilson
Contact email
Sponsor organisation
Research and Development Office, Room 2010
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research Summary
Acute Ischemic Stroke (AIS) accounts for 85% of strokes (Intercollegiate Stroke Working Party, 2016). AIS is when a blood clot causes a blockage within the brain, causing blood supply being cut off or reduced. This reduction of blood supply can result in damage to brain functioning, disability, and death. The available treatments options for AIS are Intravenous Thrombolysis (IVT), Endovascular Thrombectomy (EVT) and Bridging-therapy (IVT followed by EVT); each aim to restore blood flow. Stroke outcome is mainly considered within the context of mortality and physical disability; however, many stroke survivors experience cognitive impairment across a range of cognitive domains and difficulties with their psychological well-being. EVT and bridging therapy are both relatively new and fast-evolving medical interventions and as such there is a paucity of research comparing neuro-cognitive and psycho-social outcomes following IVT, EVT and Bridging therapy. This research will investigate the long-term neuro-cognitive and psycho-social outcomes of patients who have experienced an AIS and received IVT, EVT or Bridging Therapy within the last 7 years. May et al. (2020) found that EVT seemed to preserve long term memory, however the study suffered from underpowering. This research is an extension of the May et al (2020) study. Additional participants will be recruited via the Regional Neurosciences Neuroradiology and Stroke Department within the NHS based on inclusion / exclusion criteria. Potential participants will be sent a postal information pack inviting them to take part. A Bridging therapy group will be recruited and additional numbers will also be recruited to the IVT and EVT group to yield power. A battery of neuropsychological and psycho-social tests will be administered to each consenting participant; testing will be carried out in the Belfast Trust and take a maximum of 2hours. Test results will be pseudo anonymised and analysed using statistical analysis.
Summary of Results
Research on the neurocognitive and psychosocial sequelae following Acute Ischemic Stroke is limited. This study investigated perceptual reasoning, verbal comprehension, memory, depression, anxiety, stress and quality of life among stroke survivors relative to non-clinical norms at 1-5 years post stroke. Three treatment groups were investigated; Intravenous Thrombolysis (IVT), Endovascular Thrombectomy (EVT) and Intravenous Thrombolysis followed by Endovascular Thrombectomy (IVT+EVT). Eligible participants were recruited from a NHS Regional Neurosciences service. Sixty-seven participants underwent neurocognitive testing and completed self-report measures of anxiety, depression, stress, and quality of life. Relative to non-clinical norms, the stroke population had significantly poorer neurocognitive outcomes and higher levels of anxiety and stress but with no differences in levels of depression. Surprisingly, the stroke population self-reported significantly better quality of life compared to non-clinical norms; this is discussed further with recommendations for future research. When stratified by treatment group, the EVT group had significantly poorer neurocognitive outcomes compared to norms, however the other treatment groups did not. Further analysis suggested this is related to differences in baseline characteristics. Psycho-social outcomes between groups did not differ in relation to anxiety, depression, or stress, however the EVT group reported a significantly poorer quality of life. Improved satisfaction with the self, daily life and autonomy, social relationships and emotions was noted among both IVT and IVT+EVT groups.
REC name
Wales REC 6
REC reference
22/WA/0052
Date of REC Opinion
24 Feb 2022
REC opinion
Further Information Favourable Opinion