Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170086
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-12-06
Brief Title:
Early Neurological Trajectory and Clinical Outcomes in Brain Acute Ischemic Stroke
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Early Neurological Trajectory and Clinical Outcomes in Brain Acute Ischemic Stroke
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
Prospective identification of potential responsible blood vessels provision of intervention targets prevention of fatal and disabling cerebrovascular diseases identification of early END patients determination of clinical treatment pathways improvement of efficacy and improvement of prognosis
Detailed Description:
1 Research background Stroke is divided into ischemic stroke and hemorrhagic stroke with ischemic stroke accounting for about 70 and being the main type of stroke The branch atherosclerotic disease BAD accounts for 1015 of all acute ischemic stroke ALS mainly involving lenticular artery LSA parapontine median artery PPA thalamic geniculate body artery anterior choroidal artery Heubners artery and thalamic perforating artery Its clinical symptoms often manifest as early neurological deterioration END mainly progressive motor dysfunction PDM within 48 to 72 hours of onset with an incidence rate of approximately 17 -75 The clinical prognosis is poor
2 The purpose and significance of the research Prospective identification of potential responsible blood vessels provision of intervention targets prevention of fatal and disabling cerebrovascular diseases identification of early END patients determination of clinical treatment pathways improvement of efficacy and improvement of prognosis
3 Research contents 1 Research on the relationship between stroke responsibility vessels and the pathogenesis of END in patients based on magnetic resonance three-dimensional time leap vascular imaging technology 2 The impact of clinical interventions intravenous thrombolysis antiplatelet therapy anticoagulation statins neuroprotective drugs etc on END
4 Patient inclusion and exclusion criteria inclusion criteria
1 Acute perforating atherosclerotic stroke patients within 48 hours of onset
2 Age 18 years and 80 years old
3 Having two or more vascular risk factors including hypertension diabetes coronary heart disease hyperlipidemia smoking and obesity
4 Sign informed consent form exclusion criteria
-- --
1 Patients with large artery stroke
2 Contraindications to magnetic resonance imaging or pregnant women
3 Other vascular lesions such as aneurysms vascular dissection vasculitis and brain tumors
5 Research method Select and treat emergency stroke patients according to the research design requirements record clinical data and evaluate the timing of 7T MRI The patient underwent 7T MRI examination within 24 hours after the first diagnosis of acute stroke of the perforating artery within 24 hours after aggravation and 2 weeks after treatment according to the consensus of Chinese experts on perforating artery atherosclerosis The sequences involved include T1 T2flair DWI ADC SWI MRA and high-resolution MRI of the responsible carrier artery including cross section and longitudinal section Collect original image images search for the responsible perforating artery for stroke calculate baseline core infarct volume DWI aggravated core infarct volume DWI and final infarct volume T2 flair after 2 weeks of treatment Clinical evaluation baseline and NIHSS score after 3 months to explore the relationship between responsible blood vessels and core infarct volume and NIHSS score
6 Data statistical methods Measurement data that follow a normal distribution are expressed in the form of mean standard deviation while non normal distribution measurement data are expressed in the form of median 25 percentile -75 percentile Inter group comparison of econometric data with normal distribution and homogeneity of variance using t-test or analysis of variance The Wilcoxon rank sum test is used for inter group comparison of non normal distribution econometric data The chi square test is used for inter group comparison of count data Correlation analysis uses either Person correlation analysis or Spearman correlation analysis The consistency test between methodologies was conducted using Kappa test
2 The purpose and significance of the research Prospective identification of potential responsible blood vessels provision of intervention targets prevention of fatal and disabling cerebrovascular diseases identification of early END patients determination of clinical treatment pathways improvement of efficacy and improvement of prognosis
3 Research contents 1 Research on the relationship between stroke responsibility vessels and the pathogenesis of END in patients based on magnetic resonance three-dimensional time leap vascular imaging technology 2 The impact of clinical interventions intravenous thrombolysis antiplatelet therapy anticoagulation statins neuroprotective drugs etc on END
4 Patient inclusion and exclusion criteria inclusion criteria
1 Acute perforating atherosclerotic stroke patients within 48 hours of onset
2 Age 18 years and 80 years old
3 Having two or more vascular risk factors including hypertension diabetes coronary heart disease hyperlipidemia smoking and obesity
4 Sign informed consent form exclusion criteria
-- --
1 Patients with large artery stroke
2 Contraindications to magnetic resonance imaging or pregnant women
3 Other vascular lesions such as aneurysms vascular dissection vasculitis and brain tumors
5 Research method Select and treat emergency stroke patients according to the research design requirements record clinical data and evaluate the timing of 7T MRI The patient underwent 7T MRI examination within 24 hours after the first diagnosis of acute stroke of the perforating artery within 24 hours after aggravation and 2 weeks after treatment according to the consensus of Chinese experts on perforating artery atherosclerosis The sequences involved include T1 T2flair DWI ADC SWI MRA and high-resolution MRI of the responsible carrier artery including cross section and longitudinal section Collect original image images search for the responsible perforating artery for stroke calculate baseline core infarct volume DWI aggravated core infarct volume DWI and final infarct volume T2 flair after 2 weeks of treatment Clinical evaluation baseline and NIHSS score after 3 months to explore the relationship between responsible blood vessels and core infarct volume and NIHSS score
6 Data statistical methods Measurement data that follow a normal distribution are expressed in the form of mean standard deviation while non normal distribution measurement data are expressed in the form of median 25 percentile -75 percentile Inter group comparison of econometric data with normal distribution and homogeneity of variance using t-test or analysis of variance The Wilcoxon rank sum test is used for inter group comparison of non normal distribution econometric data The chi square test is used for inter group comparison of count data Correlation analysis uses either Person correlation analysis or Spearman correlation analysis The consistency test between methodologies was conducted using Kappa test
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