Cerebral Arterial DiseasesNCT02914288
Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI
An observational study of Cerebral Arterial Diseases and Dissecting Aneurysm of Cerebral Artery, 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 Arterial Diseases, Dissecting Aneurysm of Cerebral Artery, Intimal Dissection
- What is being tested?
- High resolution magnetic resonance imaging for intracranial vessel walls
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2018
- Phase
- Observational
- 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
Study population: Acute intracranial artery dissection
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.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Seoul, 138-736
Seung Chai Jung, PhD., 82-2-3010-4355, dynamics79@gmail.com
Seung Chai Jung, PhD.
About this study
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 prospective longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month (optional), 12 month.
- Being tested
- High resolution magnetic resonance imaging for intracranial vessel walls
- Medical subject headings
- Cerebral Arterial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution magnetic resonance imaging for intracranial vessel wallsOther
High resolution magnetic resonance imaging for intracranial vessel walls at initial (optional), 1 month, 3 month, 6 month (optional), and 12 month
What is being measured
The primary outcome is the main question the study is designed to answer.
Five proportions (%) of dissection findings
Visual detection based on PACS system by obsevers: Presence or absence of each finding (intimal flap, double lumen, intramural hematoma, aneursymal dilatation, wall enhancement): Proportions (%)= number of patients with presence of each finding/ number of all patients
Measured: 12 months
Three diameters (mm) of dissecting arterial segment and contralateral segment
Outer diameter, Inner luminal diameter, Normal diameter (mm) by measured semi-automatic in-house analysis software based on Image J
Measured: 12 months
Wall measurement (mm2) of dissecting arterial segment and contralateral segment
Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area
Measured: 12 months
Remodeling index of dissecting arterial segment and contralateral segment
Remodeling index= outer wall area of dissection segment / [(outer wall area of proximal normal looking segment + outer wall area of distal normal looking segment)/2]
Measured: 12 months
Extent (mm) of dissecting arterial segment and contralateral segment
Length (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arterial DiseasesStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
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, MD.,PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914288
- Sponsor's protocol ID
- ICD_02
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI
- ClinicalTrials.gov ID
- NCT02914288
- Acronym / sponsor ID
- ICD_02
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Bracco Corporate
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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 prospective longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month (optional), 12 month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute intracranial artery dissection
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 |
|---|---|---|
| High resolution magnetic resonance imaging for intracranial vessel wallsHigh resolution magnetic resonance imaging for intracranial vessel walls at initial (optional), 1 month, 3 month, 6 month (optional), and 12 month | Other | – |
Primary outcome
Five proportions (%) of dissection findings
Time frame: 12 months
Visual detection based on PACS system by obsevers: Presence or absence of each finding (intimal flap, double lumen, intramural hematoma, aneursymal dilatation, wall enhancement): Proportions (%)= number of patients with presence of each finding/ number of all patients
Three diameters (mm) of dissecting arterial segment and contralateral segment
Time frame: 12 months
Outer diameter, Inner luminal diameter, Normal diameter (mm) by measured semi-automatic in-house analysis software based on Image J
Wall measurement (mm2) of dissecting arterial segment and contralateral segment
Time frame: 12 months
Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area
Remodeling index of dissecting arterial segment and contralateral segment
Time frame: 12 months
Remodeling index= outer wall area of dissection segment / [(outer wall area of proximal normal looking segment + outer wall area of distal normal looking segment)/2]
Extent (mm) of dissecting arterial segment and contralateral segment
Time frame: 12 months
Length (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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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, MD.,PhD. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arterial Diseases and Dissecting Aneurysm of Cerebral Artery, 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: status not confirmed, as of the sponsor's last update on 26 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Chai Jung, MD., PhD. (82-2-3010-4355, dynamics79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five proportions (%) of dissection findings (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2016.