NCT03122002

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

March 3, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

March 30, 2017

Last Update Submit

December 3, 2022

Conditions

Keywords

Ischemic StrokeCerebral InfarctionCerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale scores

    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.

    Change from Baseline mRS score at 24 months

Secondary Outcomes (10)

  • Re-admission to the hospital

    24 months

  • Cerebral and Cardio vascular diseases

    24 months

  • Neurological deterioration-1

    Change from Baseline NIHSS score at 24 months

  • Neurological deterioration-2

    Change from Baseline FAQ score at 24 months

  • Cognitive dysfunction

    Change from Baseline MMSE score at 24 months

  • +5 more secondary outcomes

Study Arms (2)

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 TherapyDiagnostic Test: Routine Blood Test and Image ScanOther: Intravascular therapyOther: Emergency TreatmentOther: 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.

Diagnostic Test: Routine Blood Test and Image ScanOther: Medical history

Interventions

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

Also known as: Aspirin, Clopidogrel, Statin
Patients With Ischemic Stroke

Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)

Healthy ControlPatients With Ischemic Stroke

Intravascular therapy including thrombectomy

Patients With Ischemic Stroke

Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.

Patients With Ischemic Stroke

Medical history including hypertension, diabetes, hyperlipemia and ect.

Healthy ControlPatients With Ischemic Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (2)

  • Shang K, Chen X, Cheng C, Luo X, Xu S, Wang W, Liu C. Arterial Tortuosity and Its Correlation with White Matter Hyperintensities in Acute Ischemic Stroke. Neural Plast. 2022 Mar 24;2022:4280410. doi: 10.1155/2022/4280410. eCollection 2022.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Ischemic StrokeCerebral InfarctionCerebrovascular Disorders

Interventions

Drug TherapyAspirinClopidogrelHydroxymethylglutaryl-CoA Reductase InhibitorsEmergency TreatmentHealth Records, Personal

Condition Hierarchy (Ancestors)

StrokeBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TherapeuticsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Wei Wang, PhD, MD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Tongji Hospital

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 20, 2017

Study Start

March 3, 2018

Primary Completion

December 31, 2021

Study Completion

September 1, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations