Cerebral StrokeNCT02540733
MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes
An observational study of Cerebral Stroke and Diabetes Mellitus, run by Zhejiang University at 1 site in China.
Trial summary
Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Stroke, Diabetes Mellitus
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: with a definition of stroke within 3 to 7 days after onset
Who may be able to join
- first-ever ischemic stroke;
- single infarct in the distribution of the middle cerebral artery;
- no evidence of hemorrhagic infarction;
- age greater than 18 years;
- admission between 3 and 7 days after stroke onset;
- National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and
- no thrombolytic or recanalization therapies.
Who cannot join
- atrial fibrillation;
- history of neurological or psychiatric disorders;
- pre-stroke modified Rankin scale (mRS) > 1;
- life expectancy < 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,
Hangzhou, Zhejiang, 310009
Xinfeng Yu, PhD, 86-18758187391, angek-4125@163.com
Minming Zhang, PhD
About this study
Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.
- Conditions
- Cerebral Stroke, Diabetes Mellitus
- Keywords
- cerebral infarction, diabetes, rehabilitation, MRI
- Medical subject headings
- Stroke, Diabetes Mellitus, 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 |
|---|---|---|
| Diabetic stroke | Not described | |
| Non-diabetic storke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale (mRS)
scores range from 0 (no symptoms) to 6 (dead)
Measured: 6 months
National Institute of Health Stroke Score
scores ranging from 0 to 42 (the higher the score, the greater the function deficits)
Measured: 6 months
Barthel index
score ranging from 0 (totally dependent) to 100 (completely independent)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start1 Jan 2012
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minming Zhang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540733
- Sponsor's protocol ID
- 81271530
- Status last verified
- Jun 2017
- First submitted
- 26 Aug 2015
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02540733
- Acronym / sponsor ID
- 81271530
- Conditions
- Cerebral Stroke, Diabetes Mellitus
- Keywords
- cerebral infarction, diabetes, rehabilitation, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- 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.
Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic stroke | – | – |
| Non-diabetic storke | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- with a definition of stroke within 3 to 7 days after onset
Key inclusion criteria (7 listed)
- first-ever ischemic stroke;
- single infarct in the distribution of the middle cerebral artery;
- no evidence of hemorrhagic infarction;
- age greater than 18 years;
- admission between 3 and 7 days after stroke onset;
Key exclusion criteria (4 listed)
- atrial fibrillation;
- history of neurological or psychiatric disorders;
- pre-stroke modified Rankin scale (mRS) > 1;
- life expectancy < 1 year.
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
modified Rankin scale (mRS)
Time frame: 6 months
scores range from 0 (no symptoms) to 6 (dead)
National Institute of Health Stroke Score
Time frame: 6 months
scores ranging from 0 to 42 (the higher the score, the greater the function deficits)
Barthel index
Time frame: 6 months
score ranging from 0 (totally dependent) to 100 (completely independent)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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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 Stroke and Diabetes Mellitus, run by Zhejiang 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 7 inclusion and 4 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 14 Jun 2017. 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 Minming Zhang, PhD (86-0571-87315255, zhangminming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (mRS) (time frame: 6 months). The study lists 3 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 14 Jun 2017.