Moyamoya DiseaseNCT03785171
Predicative Value of Multimodal MRI in Moyamoya Disease
An observational study of Moyamoya Disease and Magnetic Resonance Imaging, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and their proximal branches, with subsequent formation of collateral vessels ("puff of smoke"). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moyamoya Disease, Magnetic Resonance Imaging
- What is being tested?
- surgical revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2018to Sep 2021
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Moyamoya disease
Who may be able to join
- DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery;
- Abnormal vascular network appeared in the brain;
- With the onset of cerebral ischemia/hemorrhage/TIA;
- No cerebral infarction or cerebral hemorrhage occurred within the last month;
- All MRI 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
- Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc.;
- Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Liu-xian Wang, MM, +86-18700916575, wang_1218@outlook.com
About this study
Official title: Multimodal Magnetic Resonance Imaging Predicting Outcome After Surgical Revascularization in Patients With Moyamoya Disease
Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and their proximal branches, with subsequent formation of collateral vessels ("puff of smoke"). In some cases, the posterior circulation can also be involved. MMD has been discovered around the world, but Asians carry the most possibility to develop this disease. Current treatment designed to prevent strokes by improving blood flow to the affected cerebral hemisphere including medical therapy and surgery. In particular, surgery included two general methods: direct and indirect revascularization. Compared with direct bypass, indirect procedures are more technically accessible and may reduce the possibility of complications, such as hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have shown great potential in evaluating perfusion in patients, and could possibly predict surgical outcome. However, there is still lack of evidence of the predictive value of MRI in evaluating clinical and angiography improvement in patients with MMD.
Read the detailed description
Imaging protocols:
3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST
Imaging evaluation:
- Transfer contrast volume value measured by DCE;
- ASL shows CBF in associated regions;
- Stoke area measured by DWI and Flair;
- PH values reflected by APT-CEST.
Treatment:
Surgery-indirect revascularization
Follow-up:
Baseline (MRI+DSA); 3-months follow-up (MRI); 6-months follow-up (MRI+DSA)
- Conditions
- Moyamoya Disease, Magnetic Resonance Imaging
- Being tested
- surgical revascularization
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical revascularizationProcedure or surgery
Indirect revascularization procedure
| Study group | Role | What they receive |
|---|---|---|
| Moyamoya disease | The cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization. Receives: Procedure: surgical revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients selection/stratification
Finding the effect of imaging biomarkers/patterns to provide therapy decision support
Measured: Three months to 6 months
Secondary outcomes (2)
Surgical outcome
Finding the effect of imaging biomarkers/patterns to reflect modified Rankin scale
Measured: Three months to 6 months
Surgical response
Finding the effect of imaging biomarkers/patterns to reflect revascularized blood flow
Measured: Three months to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start7 Sep 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies 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
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785171
- Sponsor's protocol ID
- Multimodal MRI-Moyamoya
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance Imaging Predicting Outcome After Surgical Revascularization in Patients With Moyamoya Disease
- ClinicalTrials.gov ID
- NCT03785171
- Acronym / sponsor ID
- Multimodal MRI-Moyamoya
- Conditions
- Moyamoya Disease, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Dec 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.
Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and their proximal branches, with subsequent formation of collateral vessels ("puff of smoke"). In some cases, the posterior circulation can also be involved. MMD has been discovered around the world, but Asians carry the most possibility to develop this disease. Current treatment designed to prevent strokes by improving blood flow to the affected cerebral hemisphere including medical therapy and surgery. In particular, surgery included two general methods: direct and indirect revascularization. Compared with direct bypass, indirect procedures are more technically accessible and may reduce the possibility of complications, such as hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have shown great potential in evaluating perfusion in patients, and could possibly predict surgical outcome. However, there is still lack of evidence of the predictive value of MRI in evaluating clinical and angiography improvement in patients with MMD.
Detailed description
Imaging protocols:
3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST
Imaging evaluation:
- Transfer contrast volume value measured by DCE;
- ASL shows CBF in associated regions;
- Stoke area measured by DWI and Flair;
- PH values reflected by APT-CEST.
Treatment:
Surgery-indirect revascularization
Follow-up:
Baseline (MRI+DSA); 3-months follow-up (MRI); 6-months follow-up (MRI+DSA)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moyamoya disease | – | Procedure: surgical revascularizationThe cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Moyamoya disease
Key inclusion criteria (8 listed)
- DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery;
- Abnormal vascular network appeared in the brain;
- With the onset of cerebral ischemia/hemorrhage/TIA;
- No cerebral infarction or cerebral hemorrhage occurred within the last month;
- All MRI examination performed according to study protocol;
Key exclusion criteria (3 listed)
- Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc.;
- Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.
- Pregnancy
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 |
|---|---|---|
| surgical revascularizationIndirect revascularization procedure | Procedure or surgery | Moyamoya disease |
Primary outcome
Patients selection/stratification
Time frame: Three months to 6 months
Finding the effect of imaging biomarkers/patterns to provide therapy decision support
2 secondary outcomes
Surgical outcome
Time frame: Three months to 6 months
Surgical response
Time frame: Three months to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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, MD 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 Moyamoya Disease and Magnetic Resonance Imaging, 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 8 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 24 Dec 2018. 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 Liu-xian Wang, MM (+86-18700916575, wang_1218@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients selection/stratification (time frame: Three months to 6 months). 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 24 Dec 2018.