StrokeMR-STARSNCT02580097
MR-based Stroke Mechanism and Future Risk Score
An observational study of Stroke, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic Resonance(MR) imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China. Imaging evaluation of hemodynamic status and antegrade flow were assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MRI
- How many people
- 961 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 31 Mar 2021
- How long will I take part?
- 1 Year
- 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: Ischemic stroke patients with sympton onset in 24 hours
Who may be able to join
- age≥18
- Cerebral ischemic sympton with onset in 24 hours
- pre mRS<2
- All MR examination performed according to study protocol
- Signed informed consent obtained from the patient or patient's legally authorized representative
- Having complete medical history and clinical follow up
- Imaging data can be processed
Who cannot join
- Intracranial hemorrhage
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- Known allergy to iodine previously refractory to pretreatment medications
- Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)
- History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- Severe cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic Resonance(MR) imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China. Imaging evaluation of hemodynamic status and antegrade flow were assessed. Patients were followed up to record radiological and clinical outcome. The study recruited patients from 11 centers located in 10 provinces or province-level municipalities across the northeast to the southeast of China mainland.
Read the detailed description
Patients:
Patients with cerebral ischemia sympton of onset in 24 hours were included. Baseline materials, NIH stroke scale score, modified Rankin Scale at admission, stroke causes, time from sympton onset to enrollment were recorded.
Imaging scan were conducted at admission, within 7 days after admission.
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), Perfusion weighted image(PWI), arterial spin labeling(ASL) , susceptibility-weighted imaging(SWI).
Contrast agent:
Omniscan 2ml/kg, Inject rate：3ml/s
Digital subtraction angiography(DSA) protocols:
Selective angiography and imaging phase from arterial phase to late venous phase.
Imaging evaluation:
Antegrade flow assessment from ASL Cerebral blood flow(CBF) map. Collateral flow assessment from ASL CBF map, ASL subtraction CBF map, PWI postprocessing map, FLAIR hyperintensity vascular sign.
Initial infarct volume measurement form DWI. Final infarct volume measurement from FLAIR. DWI-ASPECTS. Stroke lesions pattern assessment identified on DWI. DSA antegrade and collateral grade using modified Thrombolysis in Cerebral Infarction(TICI) scale and The American Society of Interventional and Therapeutic Neuroradiology (ASITN) collateral grading system.
Treatment:
Intravenous recombinant tissue plasminogen activator(rtPA), endovascular therapy and conventional treatment including neuro protection, ante-platelet and statin.
Follow up:
within Seven days and a month after imaging follow up and clinical stroke event and modified Rankin Scale(mRS) record in 1 year.
Note:
The original trial from 2015 to 2018 recruited patients with acute and subacute ischemic stroke, and the trial plan was changed to recruit patients with acute cerebral ischemia sympton of onset within 24 h.The study has been upgraded from a single-center study to a multi-center study since 2018.
- Conditions
- Stroke
- Being tested
- MRI
- Keywords
- Arterial Spin Labeling, Ischemic stroke, Collateral Circulation, Perfusion imaging
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI perfusion imaging, including contrast bolus perfusion imaging and arterial spin labeling.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Ischemic stroke patients with sympton onset in 24 hours and no contradiction to MRI scan Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Score
Modified Rankin Score of patients with acute stroke after 3 months will be followed up for neurological outcome assessment. mRS < 2 is defined as favorable
Measured: Three months
Secondary outcomes (3)
Final infarct volume
Final infarct volume will be measured and infarct volume growth will be calculated.
Measured: Seven days to 1 month
Stroke event
The patients will be monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
Measured: within 1 year
mortality
The patient will be monitored for death by telephone follow-up for neurological outcome assessment
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startAug 2015
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 961 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, M.D.,Ph.D., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580097
- Sponsor's protocol ID
- MR-STARS-Radiology-ChinaPLAGH
- Acronym
- MR-STARS
- Status last verified
- Aug 2021
- First submitted
- 16 Oct 2015
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyu J, Xiao S, Meng Z, Wu X, Chen W, Wang G, Niu Q, Li X, Bian Y, Han D, Guo W, Yang S, Bian X, Duan Q, Lan Y, Wang L, Zhang T, Duan C, Chen L, Tian C, Pan Y, Zhou X, Lou X; MR-STARS Investigators. Collateral-Core Ratio as a Novel Predictor of Clinical Outcomes in Acute Ischemic Stroke. Transl Stroke Res. 2023 Feb;14(1):73-82. doi: 10.1007/s12975-022-01066-9. Epub 2022 Jul 25.
PubMed 35877061
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-based Stroke Mechanism and Future Risk Score
- ClinicalTrials.gov ID
- NCT02580097
- Acronym / sponsor ID
- MR-STARS / MR-STARS-Radiology-ChinaPLAGH
- Conditions
- Stroke
- Keywords
- Arterial Spin Labeling, Ischemic stroke, Collateral Circulation, Perfusion imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 961 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Oct 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.
To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic Resonance(MR) imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China. Imaging evaluation of hemodynamic status and antegrade flow were assessed. Patients were followed up to record radiological and clinical outcome. The study recruited patients from 11 centers located in 10 provinces or province-level municipalities across the northeast to the southeast of China mainland.
Detailed description
Patients:
Patients with cerebral ischemia sympton of onset in 24 hours were included. Baseline materials, NIH stroke scale score, modified Rankin Scale at admission, stroke causes, time from sympton onset to enrollment were recorded.
Imaging scan were conducted at admission, within 7 days after admission.
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), Perfusion weighted image(PWI), arterial spin labeling(ASL) , susceptibility-weighted imaging(SWI).
Contrast agent:
Omniscan 2ml/kg, Inject rate：3ml/s
Digital subtraction angiography(DSA) protocols:
Selective angiography and imaging phase from arterial phase to late venous phase.
Imaging evaluation:
Antegrade flow assessment from ASL Cerebral blood flow(CBF) map. Collateral flow assessment from ASL CBF map, ASL subtraction CBF map, PWI postprocessing map, FLAIR hyperintensity vascular sign.
Initial infarct volume measurement form DWI. Final infarct volume measurement from FLAIR. DWI-ASPECTS. Stroke lesions pattern assessment identified on DWI. DSA antegrade and collateral grade using modified Thrombolysis in Cerebral Infarction(TICI) scale and The American Society of Interventional and Therapeutic Neuroradiology (ASITN) collateral grading system.
Treatment:
Intravenous recombinant tissue plasminogen activator(rtPA), endovascular therapy and conventional treatment including neuro protection, ante-platelet and statin.
Follow up:
within Seven days and a month after imaging follow up and clinical stroke event and modified Rankin Scale(mRS) record in 1 year.
Note:
The original trial from 2015 to 2018 recruited patients with acute and subacute ischemic stroke, and the trial plan was changed to recruit patients with acute cerebral ischemia sympton of onset within 24 h.The study has been upgraded from a single-center study to a multi-center study since 2018.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Other: MRIIschemic stroke patients with sympton onset in 24 hours and no contradiction to MRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients with sympton onset in 24 hours
Key inclusion criteria (7 listed)
- age≥18
- Cerebral ischemic sympton with onset in 24 hours
- pre mRS<2
- All MR examination performed according to study protocol
- Signed informed consent obtained from the patient or patient's legally authorized representative
Key exclusion criteria (8 listed)
- Intracranial hemorrhage
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- Known allergy to iodine previously refractory to pretreatment medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI perfusion imaging, including contrast bolus perfusion imaging and arterial spin labeling. | Other | Stroke |
Primary outcome
modified Rankin Score
Time frame: Three months
Modified Rankin Score of patients with acute stroke after 3 months will be followed up for neurological outcome assessment. mRS < 2 is defined as favorable
3 secondary outcomes
Final infarct volume
Time frame: Seven days to 1 month
Stroke event
Time frame: within 1 year
mortality
Time frame: within 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 35877061Lyu J, Xiao S, Meng Z, Wu X, Chen W, Wang G, Niu Q, Li X, Bian Y, Han D, Guo W, Yang S, Bian X, Duan Q, Lan Y, Wang L, Zhang T, Duan C, Chen L, Tian C, Pan Y, Zhou X, Lou X; MR-STARS Investigators. Collateral-Core Ratio as a Novel Predictor of Clinical Outcomes in Acute Ischemic Stroke. Transl Stroke Res. 2023 Feb;14(1):73-82. doi: 10.1007/s12975-022-01066-9. Epub 2022 Jul 25.
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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.
Xin Lou, M.D.,Ph.D. study chair
Chinese PLA General Hospital
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 Stroke, run by Chinese PLA General 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 1 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Score (time frame: Three 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 NCT02580097, which also lists 1 linked publication.
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 1 Sep 2021.