Cerebral ArteriesNCT03213470
Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using HR-MRI
A study testing magnetic resonance imaging in people with Cerebral Arteries and Dissection, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Arteries, Dissection
- What is being tested?
- magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 7 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent
- Acute intracranial artery dissection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using High Resolution Vessel Wall Magnetic Resonance Imaging
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
Read the detailed description
Inclusion criteria:
- adults with equal to or greater than 18 year-old
- confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses
- informed consent
Exclusion criteria:
- contraindicated for MRI scanning and contrast media usage
- refuse the enrollment
Outcome measures
- 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
- Demographics
- Conditions
- Cerebral Arteries, Dissection
- Being tested
- magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Intracranial artery dissection | Other | Patients with intracranial artery dissection who were diagnosed based on the clinical and radiological (including MRI) diagnoses at the symptom onset after Jan-01-2016 Receives: Other: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI
Radiological findings of HR-MRI during the study period
Measured: The time interval from initial event to outcome measurement is 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJan 2016
- Primary completion7 Apr 2019
- Study completion7 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral ArteriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Bracco Corporate
- Responsible party
- Principal investigator, Seung Chai Jung, Asan Medical Center
- Investigators
- Seung Chai Jung, Professor, Principal investigator, Associate professor, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213470
- Sponsor's protocol ID
- ICD_01
- Status last verified
- Dec 2019
- First submitted
- 7 Jul 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
Publications
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 According to Stages. Cerebrovasc Dis. 2016;42(1-2):23-31. doi: 10.1159/000444315. Epub 2016 Mar 8.
PubMed 26950228Jeong SY, Jung SC, Roh YH, Kwon SU, Kang DW, Kim JS, Choi KM, Kim S, Jeong E. Serial changes and optimal imaging windows in vessel wall MRI for unruptured intracranial artery dissection. Sci Rep. 2025 Jul 1;15(1):21864. doi: 10.1038/s41598-025-05732-4.
PubMed 40596300
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using High Resolution Vessel Wall Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03213470
- Acronym / sponsor ID
- ICD_01
- Conditions
- Cerebral Arteries, Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Bracco Corporate
- Study start
- Jan 2016
- Primary completion
- 7 Apr 2019 (actual)
- Study completion
- 7 Apr 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Inclusion criteria:
- adults with equal to or greater than 18 year-old
- confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses
- informed consent
Exclusion criteria:
- contraindicated for MRI scanning and contrast media usage
- refuse the enrollment
Outcome measures
- 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
- Demographics
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial artery dissection | Other | Other: magnetic resonance imagingPatients with intracranial artery dissection who were diagnosed based on the clinical and radiological (including MRI) diagnoses at the symptom onset after Jan-01-2016 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- Acute intracranial artery dissection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging | Other | Intracranial artery dissection |
Primary outcome
Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI
Time frame: The time interval from initial event to outcome measurement is 1 year.
Radiological findings of HR-MRI during the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Results publication: PubMed 26950228Park 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 According to Stages. Cerebrovasc Dis. 2016;42(1-2):23-31. doi: 10.1159/000444315. Epub 2016 Mar 8.
- Derived from this study: PubMed 40596300Jeong SY, Jung SC, Roh YH, Kwon SU, Kang DW, Kim JS, Choi KM, Kim S, Jeong E. Serial changes and optimal imaging windows in vessel wall MRI for unruptured intracranial artery dissection. Sci Rep. 2025 Jul 1;15(1):21864. doi: 10.1038/s41598-025-05732-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Chai Jung, Professor principal investigator
Associate professor, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging in people with Cerebral Arteries and Dissection, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI (time frame: The time interval from initial event to outcome measurement is 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213470, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.