Predictors and Prognostic Factors on the Acute Ischemic Stroke
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03122002 |
Recruitment Status :
Terminated
(Limited number of participants enrolled.)
First Posted : April 20, 2017
Last Update Posted : December 7, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
Actual Enrollment : | 1200 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 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | September 1, 2022 |

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:
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. |
- 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.
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122002
China, Hubei | |
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | |
Wuhan, Hubei, China, 430030 |
Principal Investigator: | Wei Wang, PhD, MD | Tongji Hospital |
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 Key Record Dates |
Last Update Posted: | December 7, 2022 |
Last Verified: | December 2022 |
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 |
Ischemic Stroke Cerebral Infarction Cerebrovascular Disorders |
Stroke Ischemic 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 Infarction Necrosis Clopidogrel Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |