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Predictors and Prognostic Factors on the Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03122002
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Wei Wang, Tongji Hospital

Tracking Information
First Submitted Date March 30, 2017
First Posted Date April 20, 2017
Last Update Posted Date March 6, 2018
Actual Study Start Date March 3, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2017)
Modified Rankin Scale scores [ Time Frame: Change from Baseline mRS score at 24 months ]
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03122002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 16, 2017)
  • Re-admission to the hospital [ Time Frame: 24 months ]
    Re-admission to the hospital (patients without new symptoms and admitted to the hospital simply for physical examination are not counted)
  • Cerebral and Cardio vascular diseases [ Time Frame: 24 months ]
    Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke.
  • Neurological deterioration-1 [ Time Frame: Change from Baseline NIHSS score at 24 months ]
    Neurological deterioration (NIHSS score)
  • Neurological deterioration-2 [ Time Frame: Change from Baseline FAQ score at 24 months ]
    Neurological deterioration (FAQ score)
  • Cognitive dysfunction [ Time Frame: Change from Baseline MMSE score at 24 months ]
    Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5
  • Cognitive dysfunction [ Time Frame: Change from Baseline MoCA score at 24 months ]
    Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5
  • Cerebrospinal Fluid (CSF) test [ Time Frame: 24 months ]
    Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.
  • Blood test [ Time Frame: 24 months ]
    Blood including HCY, amino acid, LDL and ect.
  • Depression [ Time Frame: 24 months ]
    Hamilton Depression Scale
  • Severe pulmonary infection [ Time Frame: 24 months ]
    Severe pulmonary infection
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors and Prognostic Factors on the Acute Ischemic Stroke
Official Title A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke
Brief Summary Through 5 years continuous observation of acute ischemic stroke patients in Neurology Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, clinical data about emergency treatment (neurological score, examination and treatment), medical data after admission (neurological score, inspection, examination and treatment) and long-term prognosis (neurological score) was collected. The outcomes were set as the score scale, all blood test index and examination index of the research objects at specific period after illness. Through statistical analysis and comparison of different in-hospital clinical data in predicting the outcome of the patients, our study will provide more evidence-based solutions for the treatment and prediction of acute ischemic stroke.
Detailed Description

The research is designed as registrated, prospective, open-labeled, blind-endpoint, and the research objects are continuously recorded. The final subgroups are blind to neurological evaluators, data inputers and statisticians.

The research is a continuous observational exploratory study. All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included. According to the current situation, it is expected to enroll approximately 5000 of eligible patients for long-term follow-up observation.

We'll use multiple linear regression analysis model to study factors and confounding factors and their interaction. And we will control the confounding factors, and make a quantitative description of the relationship between factors and outcome variables.

Missing cases will be treated as censored values, and the ratio of missing cases will be recorded. All samples will be analyzed by Intent-to-Treat (ITT) analysis. In the analysis, if the results are statistically significant, the missing cases in the exposed group will be deleted, and the missing cases in non-exposure group be added. If the results are still statistically significant, then the missing cases are defined as not affecting the analysis results.

If the heterogeneity of data is large, the objects will be analyzed in subgroups according to age or sex.

If the missing rate is greater than 20%, it is necessary to analyze the sensitivity of the whole sample.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample
Sampling Method Probability Sample
Study Population All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included.
Condition Ischemic Stroke
Intervention
  • Drug: Drug Therapy
    For this observation research, anti platelet drugs, statins and ect. would be used as clinical guidelines as usal, and statical ananysis of the relationship between these drugs and the final outcomes
    Other Names:
    • Aspirin
    • Clopidogrel
    • Statin
  • Diagnostic Test: Routine Blood Test and Image Scan
    Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
  • Other: Intravascular therapy
    Intravascular therapy including thrombectomy
  • Other: Emergency Treatment
    Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
  • Other: Medical history
    Medical history including hypertension, diabetes, hyperlipemia and ect.
Study Groups/Cohorts
  • Patients With Ischemic Stroke
    The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
    Interventions:
    • Drug: Drug Therapy
    • Diagnostic Test: Routine Blood Test and Image Scan
    • Other: Intravascular therapy
    • Other: Emergency Treatment
    • Other: Medical history
  • Healthy Control
    The patients admitted to hospital for symptoms like dizzness and headache, which later proved to be not related to cerebral vascular diseases, would be treated as control. Their medical history and the results of their routine blood test and image scan will be recorded.
    Interventions:
    • Diagnostic Test: Routine Blood Test and Image Scan
    • Other: Medical history
Publications * Qin C, Zhao XL, Ma XT, Zhou LQ, Wu LJ, Shang K, Wang W, Tian DS. Proteomic profiling of plasma biomarkers in acute ischemic stroke due to large vessel occlusion. J Transl Med. 2019 Jul 1;17(1):214. doi: 10.1186/s12967-019-1962-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 16, 2017)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ≥18 years old, of either sex
  • Confirmation by CT scan
  • Willingness to participate in the study and comply with its procedures by signing a written informed consent

Exclusion Criteria:

  • Cerebral hemorrhagic infarction confirmed by CT scan
  • Patients with severe systemic disease who are expected to survive for no more than three months
  • Unwilling to participate in the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wei Wang, PhD, MD +862783662600 wwang@vip.126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03122002
Other Study ID Numbers Know more about AIS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wei Wang, Tongji Hospital
Study Sponsor Tongji Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Wei Wang, PhD, MD Tongji Hospital
PRS Account Tongji Hospital
Verification Date March 2018