Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using HR-MRI

Dissection Clinical Trial

Official title:

Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using High Resolution Vessel Wall Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213470
• Other study ID #: ICD_01
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 7, 2019

Study information

• Verified date: December 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intracranial artery disease has been more detected with development of HR-MR. HR-MR can depict vascular wall directly and give us more information beyond the pre-existing imaging modalities such as digital subtraction angiography, magnetic resonance angiography, computed tomography angiography. Hence, HR-MR is considered to become promising imaging modality for intracranial artery disease and many studies have been published recently. However, there was not enough to differentiate various intracranial artery disease such as atherosclerosis, dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real clinical arena, intracranial artery disease is too difficult to diagnose and distinguish among the disease. Of the disease, usefulness of HR-MR has been consistently published in the detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the most important and reliable imaging method in intracranial artery dissection as of now. Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial artery dissection is dynamic vascular pathology. The geometric change is the most common among intracranial artery disease. However, there was no report about the geometric change in HR-MR. The investigators acquired retrospective data about the natural course of intracranial artery dissection in HR-MR and are preparing for publishing an article. However, the data is not prospective and not intraindividual comparison. Therefore, reliability is not enough to convince the natural course. If the investigators got prospective and intraindividual data, definite natural course of intracranial artery dissection could be acquired and would be helpful to diagnose the dissection and differentiate from other vascular pathologies. The longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. In addition, the previous retrospective study can be a stepping-stone to perform a prospective study, which can increase the success rate of the prospective study. The protocols for imaging follow-up are as followed: initial (optional), 1 month, 3 month, 6 month (optional), 12 month

Description:

Inclusion criteria:

1. adults with equal to or greater than 18 year-old

2. confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses

3. informed consent

Exclusion criteria:

1. contraindicated for MRI scanning and contrast media usage

2. refuse the enrollment

Outcome measures

1. Serial follow-up with intraindividual comparisons and interstage comparisons

• Radiological features: intimal flap, double lumen, aneurysmal dilatation, intramural hematoma, luminal stenosis, contrast enhancement degree, diameters, length, wall thickness, eccentricity index

• Clinical features: mRS, NIHSS, drug

2. Demographics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 7, 2019
• Est. primary completion date: April 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Informed consent

• Acute intracranial artery dissection

Exclusion Criteria:

• angioplasty, or stenting,

• contraindication for MR imaging,

• Hypersensitivity to gadolinium based contrast media,

• Pregnant or lactating women,

• Renal condition : eGFR < 60, 6) Patients unable and/or unwilling to comply with treatment or study instructions

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Cerebral Arteries
• Dissection

Intervention

Other:
• magnetic resonance imaging

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Bracco Corporate, Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Park KJ, Jung SC, Kim HS, Choi CG, Kim SJ, Lee DH, Suh DC, Kwon SU, Kang DW, Kim JS. Multi-Contrast High-Resolution Magnetic Resonance Findings of Spontaneous and Unruptured Intracranial Vertebral Artery Dissection: Qualitative and Quantitative Analysis A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI	Radiological findings of HR-MRI during the study period	The time interval from initial event to outcome measurement is 1 year.