AzTrials
AzTrials

Ischemic StrokeNCT03122002

Predictors and Prognostic Factors on the Acute Ischemic Stroke

An observational study of Ischemic Stroke, run by Tongji Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Drug Therapy, Routine Blood Test and Image Scan and Intravascular therapy
How many people
1,200 participants
Where
1 siteChina
Study dates
3 Mar 2018to 1 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • ≥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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke

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.

Read the 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.

Conditions
Ischemic Stroke
Being tested
Drug Therapy, Routine Blood Test and Image Scan, Intravascular therapy, Emergency Treatment, Medical history
Keywords
Ischemic Stroke, Cerebral Infarction, Cerebrovascular Disorders
Medical subject headings
Ischemic Stroke, Cerebral Infarction, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug TherapyDrug

    Also called Aspirin, Clopidogrel, Statin

    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

  • Routine Blood Test and Image ScanDiagnostic test

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

  • Intravascular therapyOther

    Intravascular therapy including thrombectomy

  • Emergency TreatmentOther

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

  • Medical historyOther

    Medical history including hypertension, diabetes, hyperlipemia and ect.

Study groups in NCT03122002
Study groupRoleWhat they receive
Patients With Ischemic StrokeThe 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.
Receives: Drug: Drug Therapy; Diagnostic Test: Routine Blood Test and Image Scan; Other: Intravascular therapy; Other: Emergency Treatment; Other: Medical history
Healthy ControlThe 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.
Receives: Diagnostic Test: Routine Blood Test and Image Scan; Other: Medical history

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Baseline mRS score at 24 months

Secondary outcomes (10)

  1. Re-admission to the hospital

    Re-admission to the hospital (patients without new symptoms and admitted to the hospital simply for physical examination are not counted)

    Measured: 24 months

  2. Cerebral and Cardio vascular diseases

    Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke.

    Measured: 24 months

  3. Neurological deterioration-1

    Neurological deterioration (NIHSS score)

    Measured: Change from Baseline NIHSS score at 24 months

  4. Neurological deterioration-2

    Neurological deterioration (FAQ score)

    Measured: Change from Baseline FAQ score at 24 months

  5. Cognitive dysfunction

    Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5

    Measured: Change from Baseline MMSE score at 24 months

  6. Cognitive dysfunction

    Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5

    Measured: Change from Baseline MoCA score at 24 months

  7. Cerebrospinal Fluid (CSF) test

    Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.

    Measured: 24 months

  8. Blood test

    Blood including HCY, amino acid, LDL and ect.

    Measured: 24 months

  9. Depression

    Hamilton Depression Scale

    Measured: 24 months

  10. Severe pulmonary infection

    Severe pulmonary infection

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start3 Mar 2018
  3. Primary completion31 Dec 2021
  4. Study completion1 Sep 2022

Why it stopped: Limited number of participants enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122002
Sponsor's protocol ID
Know more about AIS
Status last verified
Dec 2022
First submitted
30 Mar 2017
Last updated
7 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35369646

  • 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.

    PubMed 31262327

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Limited number of participants enrolled.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale scores (time frame: Change from Baseline mRS score at 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03122002, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03122002 | AzTrials