Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290271
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-11-02
Brief Title:
Arterial Wall Shear Stress After Intracranial Artery Recanalization
Sponsor:
Chonbuk National University Hospital
Organization:
Chonbuk National University Hospital
Study Overview
Official Title:
Correlation Between Changes in Arterial Wall Shear Stress and Prognosis Following Acute Major Intracranial Artery Occlusion and Recanalization
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries However studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking Time-of-flight magnetic resonance angiography TOF-MRA is extensively utilized to evaluate the intracranial arteries The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes leading to the development of the Signal Intensity Gradient SIG concept SIG has demonstrated a strong correlation with Computational Fluid Dynamics CFD a known method for reflecting wall shear stress SIG could be associated with the pathophysiology of wall shear stress We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG
Detailed Description:
1 Background The prognosis for ischemic stroke patients experiencing acute major intracranial artery occlusion is determined by a variety of factors The status of arterial recanalization and the time taken to achieve recanalization play pivotal roles in determining patient outcomes Even under similar conditions short or long-term outcomes significantly differ among patients making it challenging to solely explain with traditional risk factors An acute occlusion in a major intracranial artery results in significant alterations in cerebral blood flow enhancing flow through the Circle of Willis and collateral circulation to make up for the reduced blood supply to the affected area After thrombectomy the patterns of intracranial blood flow changes again
Wall Shear Stress WSS is the frictional resistance force exerted by blood flow as it directly interacts with the vascular walls and it serves as a critical indicator of vascular health WSS is well-known for its correlation with atherosclerotic changes Studies have shown that WSS in the internal carotid artery of ischemic stroke patients is lower compared to healthy individuals Additionally WSS was found to be reduced in the carotid artery of patients with lacunar infarctions WSS in large artery strokes was lower than in the cardioembolic group There have also been reports linking WSS to the progression of Moyamoya disease suggesting that WSS may be associated with various vascular pathophysiologies not just atherosclerotic changes
Time-of-Flight Magnetic Resonance Angiography TOF-MRA is a commonly used brain MRI technique often utilized in conjunction with CT angiography to assess the course and condition of intracranial arteries The signal intensity from MRA-TOF presents diverse distributions across different subjects and arteries Based on this the concept of Signal Intensity Gradient SIG has been derived SIG has shown a strong correlation correlation coefficient 08 with Computational Fluid Dynamics CFD a well-known method for assessing blood shear stress In patients with the large artery atherosclerosis subtype of stroke the SIG in the ipsilateral internal carotid artery was significantly lower than that on the contralateral side These findings suggest a potential association between SIG vascular shear stress and the related pathophysiology
There is no need for additional imaging beyond TOF and it is possible to measure even arteries of relatively small diameter Therefore SIG enables the analysis of shear stress pattern in major cerebral arteries before and after recanalization
2 Aims We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG
3 Target number of participants A total of 160 participants 20 individuals from each center total 8 centers
4 Sample size assessment Although there havent been many similar studies in the past a study PLoS One 2020 Sep 21159e0238620 conducted a hemodynamic evaluation before and after major vessel recanalization analyzing 11 patients Sample size estimation using GPower indicated that registration of approximately 144 patients would be necessary Taking into account factors such as image quality we anticipate an additional recruitment of about 10 resulting in a final target of 160 cases
5 Data Acquisition This study is a retrospective cohort study that involves the collection of electronic medical records and imaging data
Imaging Data to be Collected All images will be collected as DICOM files
Brain MRI Specific imaging conditions Fluid Attenuated Inversion Recovery Susceptibility Weighted Imaging T1-Weighted Imaging T2-Weighted Imaging Diffusion Weighted Imaging Apparent Diffusion Coefficient
Brain MRA Specific imaging conditions source images from both extra and intracranial TOF-MRA and 3D TOF-MRA
6 Derivation of Intravascular Shear Stress SIG Through Image Analysis The transferred DICOM files are reconstructed into 3D vasculature using a separate software VINT
SIG values for the major arterial segments within the cranial cavity are extracted
The major arterial segments are as follows and the points where laminar flow of blood is formed were selected considering the characteristics of the SIG technique
Internal Carotid Artery C1 distal segment prior to the horizontal intrapetrous segment
Vertebral Artery V4 distal segment just before the formation of the basilar artery
Basilar Artery mid to distal segment
Middle and Anterior Cerebral Arteries proximal 12 or 13 segment
Posterior Cerebral Artery P2 segment distal to the posterior communicating artery The measurements can be calculated into various SIG values average maximum minimum deviation
7 Statistical Analysis Each patient will be classified into two groups based on their blood flow characteristics before and after recanalization In a preliminary study two types of blood flow shear stress changes were observed Firstly there was a pattern in which following cerebral vascular occlusion blood flow to the ischemic area was provided and upon recanalization it returned to the typical blood flow pattern Secondly there was a case where the overall blood flow in the major cerebral vessels increased after recanalization To analyze these patterns Paired t-test and Wilcoxon Signed-Rank Test will be used While this study is expected to proceed in the same manner as the group classification in the preliminary study the classification method may be revised as the research progresses
For comparing mean values between groups Independent Samples t-Test and Mann-Whitney U Test will be utilized Categorical variables will be analyzed using the Chi-square Test or Fishers Exact Test Variables such as mRS modified Rankin Scale which are ordinal will be assessed using the Mann-Whitney U Test or Wilcoxon Rank-Sum Test to utilize the median values
Wall Shear Stress WSS is the frictional resistance force exerted by blood flow as it directly interacts with the vascular walls and it serves as a critical indicator of vascular health WSS is well-known for its correlation with atherosclerotic changes Studies have shown that WSS in the internal carotid artery of ischemic stroke patients is lower compared to healthy individuals Additionally WSS was found to be reduced in the carotid artery of patients with lacunar infarctions WSS in large artery strokes was lower than in the cardioembolic group There have also been reports linking WSS to the progression of Moyamoya disease suggesting that WSS may be associated with various vascular pathophysiologies not just atherosclerotic changes
Time-of-Flight Magnetic Resonance Angiography TOF-MRA is a commonly used brain MRI technique often utilized in conjunction with CT angiography to assess the course and condition of intracranial arteries The signal intensity from MRA-TOF presents diverse distributions across different subjects and arteries Based on this the concept of Signal Intensity Gradient SIG has been derived SIG has shown a strong correlation correlation coefficient 08 with Computational Fluid Dynamics CFD a well-known method for assessing blood shear stress In patients with the large artery atherosclerosis subtype of stroke the SIG in the ipsilateral internal carotid artery was significantly lower than that on the contralateral side These findings suggest a potential association between SIG vascular shear stress and the related pathophysiology
There is no need for additional imaging beyond TOF and it is possible to measure even arteries of relatively small diameter Therefore SIG enables the analysis of shear stress pattern in major cerebral arteries before and after recanalization
2 Aims We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG
3 Target number of participants A total of 160 participants 20 individuals from each center total 8 centers
4 Sample size assessment Although there havent been many similar studies in the past a study PLoS One 2020 Sep 21159e0238620 conducted a hemodynamic evaluation before and after major vessel recanalization analyzing 11 patients Sample size estimation using GPower indicated that registration of approximately 144 patients would be necessary Taking into account factors such as image quality we anticipate an additional recruitment of about 10 resulting in a final target of 160 cases
5 Data Acquisition This study is a retrospective cohort study that involves the collection of electronic medical records and imaging data
Imaging Data to be Collected All images will be collected as DICOM files
Brain MRI Specific imaging conditions Fluid Attenuated Inversion Recovery Susceptibility Weighted Imaging T1-Weighted Imaging T2-Weighted Imaging Diffusion Weighted Imaging Apparent Diffusion Coefficient
Brain MRA Specific imaging conditions source images from both extra and intracranial TOF-MRA and 3D TOF-MRA
6 Derivation of Intravascular Shear Stress SIG Through Image Analysis The transferred DICOM files are reconstructed into 3D vasculature using a separate software VINT
SIG values for the major arterial segments within the cranial cavity are extracted
The major arterial segments are as follows and the points where laminar flow of blood is formed were selected considering the characteristics of the SIG technique
Internal Carotid Artery C1 distal segment prior to the horizontal intrapetrous segment
Vertebral Artery V4 distal segment just before the formation of the basilar artery
Basilar Artery mid to distal segment
Middle and Anterior Cerebral Arteries proximal 12 or 13 segment
Posterior Cerebral Artery P2 segment distal to the posterior communicating artery The measurements can be calculated into various SIG values average maximum minimum deviation
7 Statistical Analysis Each patient will be classified into two groups based on their blood flow characteristics before and after recanalization In a preliminary study two types of blood flow shear stress changes were observed Firstly there was a pattern in which following cerebral vascular occlusion blood flow to the ischemic area was provided and upon recanalization it returned to the typical blood flow pattern Secondly there was a case where the overall blood flow in the major cerebral vessels increased after recanalization To analyze these patterns Paired t-test and Wilcoxon Signed-Rank Test will be used While this study is expected to proceed in the same manner as the group classification in the preliminary study the classification method may be revised as the research progresses
For comparing mean values between groups Independent Samples t-Test and Mann-Whitney U Test will be utilized Categorical variables will be analyzed using the Chi-square Test or Fishers Exact Test Variables such as mRS modified Rankin Scale which are ordinal will be assessed using the Mann-Whitney U Test or Wilcoxon Rank-Sum Test to utilize the median values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None