Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

Ischemic Stroke Clinical Trial

Official title:

A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847752
• Other study ID #: TJID-20210404TDS
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Tongji Hospital
• Contact: Dai-Shi Tian, Dr.
• Phone: 86-27-83663337
• Email: tiands[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center prospective cohort study of predictive factors related to prognosis of ischemic stroke due to large-artery atherosclerosis.

From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are admitted to the Department of Neurology or Neurosurgery, Tongji Hospital are going to be recruited. Detailed clinical data in emergency room and in-hospital will be obtained from the medical record reviews, and the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified neurologists to assess the severity of the disease in acute stage and treatment outcome during the follow-up. All cases will undergo routine blood tests, brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA. The investigators will analyze the in-hospital factors that could predict the outcome to provide more evidence-based suggestions in the treatment and prognosis of atherosclerotic ischemic cerebrovascular disease.

Description:

The detaited information about this trial is described below

1. Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.

3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.

4. Data included:

4.1 Baseline Variables: NIHSS and mRS scores before ischemic stroke 4.2 In-hospital Variables: 4.2.1 Main symptoms（1=facial paralysis 2=limb weakness 3=limb numbness 4=facial numbness 5=lalopathy 6=ataxia 7=dysphagia 8=bulbar paralysis 9=dizziness 10=nausea and vomit 11=vision disorder 12=confusion 13=headache 14=unconsciousness 15=others） NIHSS and mRS scores after admission 4.2.2 Brain CT and ASPECT scores 4.2.3 DWI 4.2.4 CTA, MRA, DSA, carotid artery ultrasound andTCD to evaluate the stenosis degree of large vessels 4.2.5 HRMR to evaluate the changes of the plaque of intracranial stenosis 4.2.6 Blood routine tests 4.2.7 HbALc and FBG 4.2.8 LDL HDL ApoA1 and ApoB 4.2.9 Cardiac TnI and NT-proBNP 4.2.10 Proteomic analysis of fresh plasma 4.2.11 Histopathological tissues and transcriptomics of CEA

5. Standard Operating Procedures 5.1 Patient recruitment: From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are admitted to the Department of Neurology and Neurosurgery, Tongji Hospital are going to be recruited 5.2 Data collection: Detailed clinical data in emergency room and in-hospital will be obtained from the medical record reviews, and the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified neurologists to assess the severity of the disease in acute stage and clinical outcome during the follow-up. All cases would undergo routine blood tests, brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA.

5.3 Data management, The research data is reviewed by an Independent Research Panel.

5.4 Data analysis: Biostatisticians from the Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology will conduct statistical analysis

6. Sample size assessment: About 1000 cases.

7. Plan for missing data: The number of lost cases will be treated as the deleted value and the lost rate will be indicated. Complete sample intentionality analysis and intent-to-treat (ITT) analysis would be performed on the end points. During the analysis, if there is a statistical difference in the results, the number of participants lost in the exposed group will be deleted, and the number of participants lost to in the non-exposed group will be added. If there is still a statistical difference in the results, the loss of follow-up will not have an impact on the analysis results of this group.

8. Statistical analysis: All statistical data would be analyzed by the SPSS Software 24.0 version. Continuous variables would be reported as median (range, minimum-maximum), which would be compared by Mann-Whitney test, and categorical data would be represented as percentages and frequencies, which would be compared by the two-tailed Fisher's exact test or one-way ANOVA. P<0.05 would be considered statistically significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Ischemic stroke due to large-artery atherosclerosis has been proved by clinical symptoms and imaging examinations.

• Symptomatic superior arch stenosis >50%

• Asymptomatic superior arch stenosis was >70%

• written informed consent was obtained from patients or their surrogates before enrollment.

Exclusion Criteria:

• Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)

• With severe systemic disease, are expected to survive < 3 months

• Patients will not able to provide continuous follow-up information

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Large-Artery Atherosclerosis (Embolus/Thrombosis)
• Stroke
• Thrombosis

Intervention

Procedure:
• carotid artery stenting
common treatments for carotid artery stenosis
• carotid endarterectomy
common treatments for carotid artery stenosis

Drug:
• Aspirin
the dosage and duration
• Clopidogrel
the dosage and duration
• Anticoagulant
the dosage and duration
• Statin
the dosage and duration
• PCSK9 inhibitor
the dosage and duration

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	Death during the follow-up in every single reason	3-6 months after onset.
Primary	Stroke of any kind	Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage	3-6 months after onset.
Secondary	Rehospitalization	The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation	1 month to 24 months after onset.
Secondary	National Institute of Health stroke scale (NIHSS score)	The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome.	1 month to 24 months after onset.
Secondary	modified Ranking score (mRS)	The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.	1 month to 24 months after onset.