Cerebral InfarctionENDAISNCT03703986
Early Neurological Deterioration in Patients With Acute Ischemic Stroke
An observational study of Cerebral Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study set out to explore the risk factors of early neurological deterioration (END) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 30 Jan 2019
- 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: Patients admitted to First Affiliated Hospital of Nangjing Medical University from January 2015 to April 2018 were collected retrospectively.
Who may be able to join
- Subjects with acute ischemic stroke
- Subjects with detailed progress notes
Who cannot join
- Subjects with thrombolysis therapy
- Subjects with transient ischemia attach
- Subjects complicated with seriously underlying diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing
Hong Cheng, 008613815877695, ch8706@hotmail.com
About this study
Official title: Explore the Causes and Predictors of Early Neurological Deterioration Occurred in Patients With Acute Ischemic Stroke
This study set out to explore the risk factors of early neurological deterioration (END) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors.
Read the detailed description
END refers to the illness aggravation occurred in the early stage of stroke and often indicates a poor outcome. Some clinical scales may play an important role in its diagnoses and treatments. Across the reviewed studies, the risk factors of END, which included biochemical parameters, neuroimaging, ect. were explored incompletely and the effective predictors of END is unknown. We aimed to explore the risk factors of END and investigate the predictive value of certain scales.
- Conditions
- Cerebral Infarction
- Keywords
- deterioration, risk factors, predictors
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| END group | The patients in this group had an elevation of ≥ 2 points in the National Institute of Health Stroke Scale (NIHSS) within 7 days of stroke onset. | |
| non-END group | The patients in this group had a slight increase of < 2 points or a decrease in NIHSS within 7 days of stroke onset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale (NIHSS) can assess the severity of stroke. The total score of NIHSS ranges from 0 to 42, with higher scores indicating better neurological function.
Measured: 7 days
Canadian Neurological Scale
Canadian Neurological Scale (CNS) can assess the severity of stroke as well. The total score of CNS ranges from 0 to 10, with higher scores indicating worse neurological function.
Measured: 7 days
Secondary outcomes (2)
Blood parameters
The blood parameters included total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein. The normal range of them were 3 mmol·L-1 to 5.7 mmol·L-1, 0 mmol·L-1 to 2.25 mmol·L-1, 2.6 mmol·L-1 to 4.1 mmol·L-1, 1.03 mmol·L-1 to 1.55 mmol·L-1, respectively.
Measured: 7days
Neuroimaging data
Intracranial stenosis was defined as ≥ 50% narrowing in any of the intracranial arteries. Multi-vessel lesions were recorded when the number of cerebral vascular stenosis was greater than 2.
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start20 Nov 2018
- Primary completion25 Jan 2019
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703986
- Sponsor's protocol ID
- 2014-SR-099
- Acronym
- ENDAIS
- Status last verified
- Jan 2019
- First submitted
- 26 Jun 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Causes and Predictors of Early Neurological Deterioration Occurred in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03703986
- Acronym / sponsor ID
- ENDAIS / 2014-SR-099
- Conditions
- Cerebral Infarction
- Keywords
- deterioration, risk factors, predictors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study set out to explore the risk factors of early neurological deterioration (END) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors.
Detailed description
END refers to the illness aggravation occurred in the early stage of stroke and often indicates a poor outcome. Some clinical scales may play an important role in its diagnoses and treatments. Across the reviewed studies, the risk factors of END, which included biochemical parameters, neuroimaging, ect. were explored incompletely and the effective predictors of END is unknown. We aimed to explore the risk factors of END and investigate the predictive value of certain scales.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| END group | – | –The patients in this group had an elevation of ≥ 2 points in the National Institute of Health Stroke Scale (NIHSS) within 7 days of stroke onset. |
| non-END group | – | –The patients in this group had a slight increase of < 2 points or a decrease in NIHSS within 7 days of stroke onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to First Affiliated Hospital of Nangjing Medical University from January 2015 to April 2018 were collected retrospectively.
Key inclusion criteria (2 listed)
- Subjects with acute ischemic stroke
- Subjects with detailed progress notes
Key exclusion criteria (3 listed)
- Subjects with thrombolysis therapy
- Subjects with transient ischemia attach
- Subjects complicated with seriously underlying diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
National Institutes of Health Stroke Scale
Time frame: 7 days
National Institutes of Health Stroke Scale (NIHSS) can assess the severity of stroke. The total score of NIHSS ranges from 0 to 42, with higher scores indicating better neurological function.
Canadian Neurological Scale
Time frame: 7 days
Canadian Neurological Scale (CNS) can assess the severity of stroke as well. The total score of CNS ranges from 0 to 10, with higher scores indicating worse neurological function.
2 secondary outcomes
Blood parameters
Time frame: 7days
Neuroimaging data
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction, run by The First Affiliated Hospital with Nanjing Medical University 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 2 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Cheng, MD (+0086 2583674680, ch8706@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.