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

June 18, 2024 updated by: Daishi Tian, Tongji Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with ischemic stroke due to large-artery atherosclerosis admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from March 1, 2021 - December 31, 2026

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 3-6 months after onset.
Death during the follow-up in every single reason
3-6 months after onset.
Stroke of any kind
Time Frame: 3-6 months after onset.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehospitalization
Time Frame: 1 month to 24 months after onset.
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.
National Institute of Health stroke scale (NIHSS score)
Time Frame: 1 month to 24 months after onset.
The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome.
1 month to 24 months after onset.
modified Ranking score (mRS)
Time Frame: 1 month to 24 months after onset.
The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.
1 month to 24 months after onset.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: Dai-Shi Tian, Dr., Tongji Hospital
  • Principal Investigator: Chuan Qin, Dr., Tongji Hospital
  • Principal Investigator: Jun Xiao, Dr., Tongji Hospital
  • Principal Investigator: Ke Shang, Dr., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJID-20210404TDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 12 months after publication

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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