Investigation of Vascular Inflammation in Migraine Using Molecular Nano-imaging and Black Blood Imaging MRI
1 other identifier
interventional
34
1 country
1
Brief Summary
The investigators aim to investigate inflammation of cranial and meningeal arteries during pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticles and black blood imaging (BBI) MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 27, 2022
July 1, 2022
2.8 years
July 31, 2015
July 26, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Change in USPIO uptake during attacks of unilateral migraine without aura compared to baseline
On the first study day, migraine is induced with cilostazol, and intravenous infusion of Feraheme (USPIO) is delivered. On the second study day, USPIO-MRI is performed.
34 hours
Change in arterial wall thickness during attacks of unilateral migraine without aura compared to baseline
On the first study day, migraine is induced with cilostazol, and 4 hours after cilostazol ingestion, BBI-MRI is performed.
6 hours
Change in arterial circumference as a proxy measure for vascular inflammation during attacks of unilateral migraine without aura compared to baseline
On the first study day, migraine is induced with cilostazol, and at 4 hours and 28 hours after cilostazol ingestion, MR angiography is performed.
34 hours
Change in USPIO uptake during attacks of unilateral migraine without aura before and after sumatriptan
On the first study day, migraine is induced with cilostazol and subsequently treated with sumatriptan. Intravenous infusion of Feraheme (USPIO) is delivered, and on the second study day, USPIO-MRI is performed.
36 hours
Change in arterial wall thickness during attacks of unilateral migraine without aura before and after sumatriptan
On the first study day, migraine is induced with cilostazol, and 4 hours after cilostazol ingestion, BBI-MRI is performed. Subjects are treated with sumatriptan, and BBI-MRI is repeated.
7 hours
Change in arterial circumference as a proxy measure for vascular inflammation during unilateral attacks of migraine without aura before and after sumatriptan
On the first study day, migraine is induced with cilostazol, and 4 hours after cilostazol, MR angiography is performed. Subjects are treated with sumatriptan, and MR angiography is repeated. 28 hours after cilostazol ingestion, MR angiography is performed again.
36 hours
Study Arms (4)
Vascular inflammation
EXPERIMENTALSubjects with habitual unilateral migraine without aura, undergo a baseline MRI scan, undergo pharmacological induction of a migraine attack, and subsequently are MRI scanned prior to (BBI-MRI) and after Feraheme infusion (USPIO-MRI ).
Effect of sumatriptan
EXPERIMENTALSubjects with habitual unilateral migraine without aura, undergo a baseline MRI scan and then undergo pharmacological induction of a migraine attack. Sumatriptan is given and subjects subsequently undergo MRI scans prior to (BBI-MRI) and after Feraheme infusion (USPIO-MRI).
Pilot w/o cilostazol
EXPERIMENTALSubjects without habitual unilateral migraine without aura undergo a baseline MRI scan. Subjects are then MRI scanned prior to (BBI-MRI) and after Feraheme infusion (USPIO-MRI).
Pilot w/ cilostazol
EXPERIMENTALSubjects without habitual unilateral migraine without aura undergo a baseline MRI scan and then receive cilostazol. Subjects are then MRI scanned prior (BBI-MRI) to and after Feraheme infusion (USPIO-MRI).
Interventions
Feraheme is an USPIO agent, which will be applied as a contrast agent to visualize vascular inflammation in unilateral migraine without aura.
Cilostazol will be applied to provoke migraine attacks in migraineurs
USPIO-MRI scans will be performed in order to assess possible vascular inflammation associated with migraine attacks.
Black blood MRI scans will be performed in order to asses changes in vessel wall thickness due to possible vascular inflammation associated with migraine attacks.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Subject has migraine without aura according to criteria of the International Headache Society (IHS)
- Subject has unilateral migraine 70% of the time
- Migraine can be pharmacologically provoked in the subject using cilostazol.
- Subject is on birth control
- Subject has no other medical history
You may not qualify if:
- Subject suffers from bilateral migraine
- Subject suffers from migraine with aura
- Subject suffers from other primary headaches as specified by IHS criteria
- Pregnant or breast feeding subjects
- Subjects with contraindications for undergoing MRI scans
- Any known drug allergy
- Any signs or disorders of iron overload, including but not limited to hemosiderosis and porphyria cutanea tarda
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
Related Publications (1)
Khan S, Amin FM, Fliedner FP, Christensen CE, Tolnai D, Younis S, Olinger ACR, Birgens H, Daldrup-Link H, Kjaer A, Larsson HBW, Lindberg U, Ashina M. Investigating macrophage-mediated inflammation in migraine using ultrasmall superparamagnetic iron oxide-enhanced 3T magnetic resonance imaging. Cephalalgia. 2019 Oct;39(11):1407-1420. doi: 10.1177/0333102419848122. Epub 2019 May 19.
PMID: 31104505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabrina Khan, MD
Danish Headache Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor and PhD student
Study Record Dates
First Submitted
July 31, 2015
First Posted
September 15, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 27, 2022
Record last verified: 2022-07