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Predicative Value of Multimodal MRI in Moyamoya Disease

NCT ID: NCT03785171

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-07

Study Completion Date

2021-09-30

Brief Summary

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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

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Imaging protocols:

3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST

Imaging evaluation:

1. Transfer contrast volume value measured by DCE;
2. ASL shows CBF in associated regions;
3. Stoke area measured by DWI and Flair;
4. 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

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Moyamoya Disease Magnetic Resonance Imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Moyamoya disease

The cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization.

surgical revascularization

Intervention Type PROCEDURE

Indirect revascularization procedure

Interventions

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surgical revascularization

Indirect revascularization procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Lou

Deputy Director of Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Lou, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu-xian Wang, MM

Role: CONTACT

Phone: +86-18700916575

Email: [email protected]

Facility Contacts

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Liu-xian Wang, MM

Role: primary

Other Identifiers

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Multimodal MRI-Moyamoya

Identifier Type: -

Identifier Source: org_study_id