Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530927
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Microclots and Neutrophil Activation as Potential Indicators for Stroke Risk and Reperfusion Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Micro-clots and Neutrophil Activation as Potential Indicators for Stroke Risk and Reperfusion Failure The CLOTSAFE - Study Micro-CLOTs Stroke Risk Activated Neutrophils Reperfusion FailurE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLOTSAFE
Brief Summary:
Stroke remains a major health burden worldwide Many patients are severely disabled and stay in need of care Mechanical thrombectomy has dramatically improved outcomes for stroke patients with large vessel occlusions yet 40-50 of patients with successful recanalization remain severely disabled despite successful recanalization a scenario called futile recanalization One of the causes for this lack of treatment effect is capillary obstruction or no reflow potentially resulting from activated neutrophils and micrometer-sized blood clots To address this issue we employ digital holotomographic and atomic force microscopy to investigate the structural and chemical characteristics of blood and clot material in stroke patients and individuals at high risk of developing a stroke Our study elucidates the association of activated neutrophils and microclots with stroke risk and may be associated with clinical outcome stroke ethology and reperfusion failure in patients with stroke Leveraging label-free microscopy tools could potentially lead to the discovery of new biomarkers for individualized stroke treatment and prevention ultimately offering rapid identification of at risk patients and improving clinical outcomes
Detailed Description:
Background
Stroke remains a major health burden worldwide Many patients are severely disabled and stay in need of care Since introducing mechanical thrombectomy as a therapeutic option clinical outcome has drastically improved over the last few years However despite successful macrovascular reperfusion recanalization patients with stroke still have a significant risk about 40-50 of remaining severely disabled a scenario called futile recanalization One of the causes for this lack of treatment effect is capillary obstruction or no reflow potentially resulting from activated neutrophils and micrometer-sized blood clots Previous work in rodent stroke models demonstrated that removal of these capillary stalls indeed improves reperfusion and recovery after stroke However there is a lack of knowledge regarding the role of neutrophils or microclots in patients with stroke and their potential to indicate reperfusion failure
Aim
The goal of our study is to search for activated neutrophils and microclots in peripheral blood samples from patients with stroke We anticipate that neutrophil and microclot characteristics such as size shape or surface structure may indicate stroke risk and may be associated with clinical outcome stroke ethology and reperfusion failure in patients with stroke Our goal is to improve the prediction of stroke risk and treatment success
Methodology
We plan to prospectively include 500 patients with acute and chronic stroke as well as a control group We have teamed up with biophysicists from the Swiss Federal Laboratories for Materials Science EMPA using the novel microscopic tools 3D rotational digital tomography DHTM to achieve an unprecedented resolution of less than 10 μm for detection of altered neutrophil phenotypes and microclots in peripheral blood samples Furthermore in patients undergoing mechanical thrombectomy retrieved clots will be analyzed with high-density micro-computertomography micro-CT Quantity mechanical and structural properties of microclots and neutrophils will be correlated with risk of reperfusion failure stroke recurrence and clinical recovery Analyses of clots from patients with large vessel occlusion will be used to derive risk of reperfusion failure along with most likely source of the clot and thus most likely stroke etiology
Potential Significance
Current diagnostic tools are insufficient to predict response to treatment clot source or stroke recurrence risk Our project has the potential to discover new clinically applicable biomarkers identifying patients at risk within a few hours enabling individualized stroke treatment and prevention
Stroke remains a major health burden worldwide Many patients are severely disabled and stay in need of care Since introducing mechanical thrombectomy as a therapeutic option clinical outcome has drastically improved over the last few years However despite successful macrovascular reperfusion recanalization patients with stroke still have a significant risk about 40-50 of remaining severely disabled a scenario called futile recanalization One of the causes for this lack of treatment effect is capillary obstruction or no reflow potentially resulting from activated neutrophils and micrometer-sized blood clots Previous work in rodent stroke models demonstrated that removal of these capillary stalls indeed improves reperfusion and recovery after stroke However there is a lack of knowledge regarding the role of neutrophils or microclots in patients with stroke and their potential to indicate reperfusion failure
Aim
The goal of our study is to search for activated neutrophils and microclots in peripheral blood samples from patients with stroke We anticipate that neutrophil and microclot characteristics such as size shape or surface structure may indicate stroke risk and may be associated with clinical outcome stroke ethology and reperfusion failure in patients with stroke Our goal is to improve the prediction of stroke risk and treatment success
Methodology
We plan to prospectively include 500 patients with acute and chronic stroke as well as a control group We have teamed up with biophysicists from the Swiss Federal Laboratories for Materials Science EMPA using the novel microscopic tools 3D rotational digital tomography DHTM to achieve an unprecedented resolution of less than 10 μm for detection of altered neutrophil phenotypes and microclots in peripheral blood samples Furthermore in patients undergoing mechanical thrombectomy retrieved clots will be analyzed with high-density micro-computertomography micro-CT Quantity mechanical and structural properties of microclots and neutrophils will be correlated with risk of reperfusion failure stroke recurrence and clinical recovery Analyses of clots from patients with large vessel occlusion will be used to derive risk of reperfusion failure along with most likely source of the clot and thus most likely stroke etiology
Potential Significance
Current diagnostic tools are insufficient to predict response to treatment clot source or stroke recurrence risk Our project has the potential to discover new clinically applicable biomarkers identifying patients at risk within a few hours enabling individualized stroke treatment and prevention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None