Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361017
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-11
First Post:
2024-03-26
Brief Title:
The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Research of the Prediction of Hemorrhage Transformation and Clinical Outcome by Cerebral Autoregulation After Endovascular Thrombectomy in Acute Ischemic Stroke Patients Caused by Middle Cerebral Artery or Internal Carotid Artery Occlusion
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
PHASE
Brief Summary:
This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation dCA after endovascular thrombectomy EVT in acute ischemic stroke AIS patients And analysis the relationship between the dCA damage degree and hemorrhage transformation HT and clinical outcome
Patients patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT
dCA Examination dCA examinations were performed at 24 hours 48 hours 72 hours and 5 days after EVT
The objectives of the study were as follows The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes
Patients patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT
dCA Examination dCA examinations were performed at 24 hours 48 hours 72 hours and 5 days after EVT
The objectives of the study were as follows The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes
Detailed Description:
Part of the data from March 2022 to March 2022 was obtained but it was still need more data and need a one-year follow-up of the data Therefore this is a 4 years prospective cohort study
The objectives of the study were as follows This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation dCA after endovascular thrombectomy EVT in acute ischemic stroke AIS patients And analysis the relationship between the dCA damage degree and hemorrhage transformation HT and clinical outcomes To explore the predictors of HT and adverse clinical outcomes
A To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT
B dCA examinations were performed at 24 hours 48 hours 72 hours and 5 days after EVT
C The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT
D Utilizing the modified Rankin Scale mRS the clinical prognosis was assessed 3 months and 1 year after stroke The outcomes were dichotomized according to the mRS score favorable outcome mRS 2 and unfavorable outcome mRS 3-6 During the telephone call follow-up the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score
E All tests are non-invasive
The objectives of the study were as follows This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation dCA after endovascular thrombectomy EVT in acute ischemic stroke AIS patients And analysis the relationship between the dCA damage degree and hemorrhage transformation HT and clinical outcomes To explore the predictors of HT and adverse clinical outcomes
A To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT
B dCA examinations were performed at 24 hours 48 hours 72 hours and 5 days after EVT
C The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT
D Utilizing the modified Rankin Scale mRS the clinical prognosis was assessed 3 months and 1 year after stroke The outcomes were dichotomized according to the mRS score favorable outcome mRS 2 and unfavorable outcome mRS 3-6 During the telephone call follow-up the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score
E All tests are non-invasive
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