Predicative Value of Multimodal MRI in Moyamoya Disease

NCT03785171 | Unknown

• 1 other identifier: Multimodal MRI-Moyamoya
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moyamoya Disease; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Patients selection/stratification

  Finding the effect of imaging biomarkers/patterns to provide therapy decision support

  Three months to 6 months

Secondary Outcomes (2)

• Surgical outcome

  Three months to 6 months

• Surgical response

  Three months to 6 months

Study Arms (1)

Moyamoya disease

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

Procedure: surgical revascularization

Interventions

surgical revascularization PROCEDURE

Indirect revascularization procedure

Moyamoya disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Moyamoya disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xin Lou, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Liu-xian Wang, MM

CONTACT

+86-18700916575; wang_1218@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Radiology

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: September 7, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

CN (1)