Predicative Value of Multimodal MRI in Moyamoya Disease

Magnetic Resonance Imaging Clinical Trial

Official title:

Multimodal Magnetic Resonance Imaging Predicting Outcome After Surgical Revascularization in Patients With Moyamoya Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785171
• Other study ID #: Multimodal MRI-Moyamoya
• Status: Recruiting
• Start date: September 7, 2018
• Est. completion date: September 2021

Study information

• Verified date: December 2018
• Source: Chinese PLA General Hospital
• Contact: Liu-xian Wang, MM
• Phone: +86-18700916575
• Email: wang_1218[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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"). 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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Moyamoya Disease

Intervention

Procedure:
• surgical revascularization
Indirect revascularization procedure

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients selection/stratification	Finding the effect of imaging biomarkers/patterns to provide therapy decision support	Three months to 6 months
Secondary	Surgical outcome	Finding the effect of imaging biomarkers/patterns to reflect modified Rankin scale	Three months to 6 months
Secondary	Surgical response	Finding the effect of imaging biomarkers/patterns to reflect revascularized blood flow	Three months to 6 months