Predictors and Prognostic Factors on the Acute Ischemic Stroke

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

Study Description

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.

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

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 Design

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke
• Actual Study Start Date: March 3, 2018
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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)
2. 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.
3. Neurological deterioration-1 [ Time Frame: Change from Baseline NIHSS score at 24 months ]
   Neurological deterioration (NIHSS score)
4. Neurological deterioration-2 [ Time Frame: Change from Baseline FAQ score at 24 months ]
   Neurological deterioration (FAQ score)
5. 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
6. 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
7. Cerebrospinal Fluid (CSF) test [ Time Frame: 24 months ]
   Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.
8. Blood test [ Time Frame: 24 months ]
   Blood including HCY, amino acid, LDL and ect.
9. Depression [ Time Frame: 24 months ]
   Hamilton Depression Scale
10. Severe pulmonary infection [ Time Frame: 24 months ]
    Severe pulmonary infection

Biospecimen Retention:   Samples With DNA

blood sample

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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; 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wei Wang, Vice President of Tongji Hospital, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03122002
• Other Study ID Numbers: Know more about AIS
• First Posted: April 20, 2017
• Last Update Posted: March 6, 2018
• Last Verified: March 2018

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; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Aspirin; Clopidogrel; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists