Predicative Value of Multimodal MRI in Moyamoya Disease

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.

Study Overview

• Status: Unknown
• Conditions: Moyamoya Disease; Magnetic Resonance Imaging
• Intervention / Treatment: Procedure: surgical revascularization

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:

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)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Liu-xian Wang, MM; Phone Number: +86-18700916575; Email: wang_1218@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Liu-xian Wang, MM; Phone Number: +86-18700916575; Email: wang_1218@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Moyamoya disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moyamoya disease; The cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization.	Procedure: surgical revascularization; Indirect revascularization procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients selection/stratification	Finding the effect of imaging biomarkers/patterns to provide therapy decision support	Three months to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical outcome	Finding the effect of imaging biomarkers/patterns to reflect modified Rankin scale	Three months to 6 months
Surgical response	Finding the effect of imaging biomarkers/patterns to reflect revascularized blood flow	Three months to 6 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Moyamoya Disease
• Other Study ID Numbers: Multimodal MRI-Moyamoya

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No