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Predictors and Prognostic Factors on the Acute Ischemic Stroke

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2017 by Wei Wang, Tongji Hospital
Sponsor:
Information provided by (Responsible Party):
Wei Wang, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT03122002
First received: March 30, 2017
Last updated: April 16, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Ischemic Stroke Drug: Drug Therapy Diagnostic Test: Routine Blood Test and Image Scan Other: Intravascular therapy Other: Emergency Treatment Other: Medical history

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Wei Wang, Tongji Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
blood sample

Estimated Enrollment: 5000
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
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.
Diagnostic Test: Routine Blood Test and Image Scan
Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
Other: Medical history
Medical history including hypertension, diabetes, hyperlipemia and ect.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03122002

Contacts
Contact: Wei Wang, PhD, MD +862783662600 wwang@vip.126.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Wei Wang, PhD, MD    +862783662600    wwang@vip.126.com   
Principal Investigator: Wei Wang, PhD, MD         
Sponsors and Collaborators
Tongji Hospital
Investigators
Principal Investigator: Wei Wang, PhD, MD Tongji Hospital
  More Information

Responsible Party: Wei Wang, Vice President of Tongji Hospital, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03122002     History of Changes
Other Study ID Numbers: Know more about AIS
Study First Received: March 30, 2017
Last Updated: April 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Wang, Tongji Hospital:
Ischemic Stroke
Cerebral Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 19, 2017