Reversible Cerebral Vasoconstriction SyndromeNCT02756416
Perfusion MRI in Reversible Cerebral Vasoconstriction Syndrome
A study testing MRI brain, ASL-MRI brain and MRA brain in people with Reversible Cerebral Vasoconstriction Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these data at multiple time points during RCVS progression, the investigators will assess the relationship between vasoconstriction and downstream… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reversible Cerebral Vasoconstriction Syndrome
- What is being tested?
- MRI brain, ASL-MRI brain and MRA brain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to May 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients aged 18-60 years old
- Able to give informed written consent
- Clinical presentation suggestive of RCVS
- Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
Who cannot join
- Evidence of brain haemorrhage or significant brain pathology on Computed Tomography (CT) scan performed as standard National Health Service (NHS) care
- Any history of significant cerebrovascular disease
- Pregnancy or breastfeeding
- MRI contraindications (e.g. metal implants or pacemaker) as indicated on the MRI Safety Screening Questionnaire
- Significant claustrophobia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK
Nottingham, Nottinghamshire, NG7 2UH
Nikos Evangelou, FRCP, D.Phil, 00441159709735, nikos.evangelou@nottingham.ac.uk
Yasser Falah, MBChB, MRCP, 00441158231082, yasser.falah@nottingham.ac.uk
About this study
This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these data at multiple time points during RCVS progression, the investigators will assess the relationship between vasoconstriction and downstream perfusion and determine the role of these imaging techniques in early and accurate diagnosis of RCVS. The investigators also aim to investigate whether early imaging abnormalities can predict RCVS complications and clinical outcomes.
Read the detailed description
Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a group of conditions characterised by prolonged but reversible multifocal narrowing of the cerebral arteries. It presents typically as acute severe headache, usually recurrent and thunderclap in character, with or without additional symptoms and signs. Adverse complications associated with RCVS can be devastating especially if not recognised early; depending on the degree of vasoconstriction, RCVS may be associated with cortical subarachnoid haemorrhage (in approximately 34% of patients), ischaemic infarction (6-39% of patients), or concomitant posterior reversible encephalopathy syndrome (PRES, 9-38% of patients). RCVS may also present as parenchymal brain haemorrhage in 20% of cases. The data on complications rate highlight the uncertainty about the condition and indicate need for more research to better characterise the evolution of the pathology; hence need for this study as it is prospective and longitudinal.
The hallmark of RCVS is vasoconstriction seen on vascular imaging scans and typically reverses within 3 months. Prevalence of radiological vasoconstriction seen on magnetic resonance angiography (MRA) in RCVS is reported to be between 60-90% and typically appears as diffuse segmental constriction of large and medium sized vessels lasting 4-12 weeks. The main advantage of MRA is that it can be performed without the use of a radioactive tracer, thus providing a safe method for repeat observations of vascular pathology. Imaging is often negative in first 4-5 days following the onset of headache; The mean time to detect abnormality on vascular imaging has been reported as 8 days after headache onset. RCVS symptoms usually resolves by 1 month after presentation, however the adverse complications associated with RCVS may have lasting consequences as described above. Magnetic resonance imaging (MRI) is an excellent tool for characterising brain changes during the progression and resolution of RCVS. Standard structural images can identify complications of RCVS, such as bleeding, ischaemia, and PRES.
Finally, Arterial Spin Labeling (ASL) MRI can be used to non-invasively quantify perfusion of brain tissue, providing a measure of the impact of upstream arterial vasoconstriction on local cortical regions.
Cortical perfusion has not yet been extensively studied in RCVS; at time of writing, only two case reports have been published. Rosenbloom and Singhal reported a case of RCVS induced by carotid endarterectomy following a frontal lobe ischaemic stroke. Perfusion MRI showed unilateral hypo-perfusion, mainly affecting internal watershed areas with superficial cortical regions being relatively spared. In a second study, ASL-MRI was performed on a 50-year-old man with RCVS who presented with severe recurrent headaches and neurological deficits (localising to the right hemisphere). ASL-MRI demonstrated significant hypo-perfusion in the right parieto-occipital lobe, but no infarct was seen on diffusion imaging. At 12 weeks, there was complete resolution of cerebral vasoconstriction on angiography and normal perfusion findings on ASL-MRI.
These case studies suggest that perfusion MRI can offer an additional tool to confirm and understand RCVS. ASL-MRI is a non-invasive, radiation and contrast-free technique that can be performed at multiple time points to monitor changes in perfusion over the time period of RCVS resolution and assess response to potential therapeutics.
One of the disadvantages of ASL-MRI is a low signal to noise ratio, this can be addressed by using high-field MRI at 3 Tesla (3T). In addition, 3T MRI can provide very good spatial resolution. The University of Nottingham represents one of the leading international research centres with experience in using high and ultra-high field MRI for investigating different neurological diseases such as multiple sclerosis and brain tumours with excellent results. Applying advanced non-invasive MRI techniques in this study will be a significant advantage as we investigate RCVS, understand the pathophysiology, and assess brain perfusion in multiple time points.
- Being tested
- MRI brain, ASL-MRI brain, MRA brain
- Keywords
- Reversible Cerebral Vasoconstriction Syndrome (RCVS), Arterial spin labeling (ASL) MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI brainDevice
Standard MRI brain will be performed on each participant to look at brain structure and exclude complications of RCVS (if any).
ASL-MRI brainDevice
ASL-MRI is a non-contrast scan used to measure cortical cerebral blood flow (CBF) in areas supplied by major arteries (Circle of Willis).
MRA brainDevice
MR angiography scan looks at blood vessels structure. We expect to see constriction (narrowing) of the major arteries in RCVS cases.
| Study group | Role | What they receive |
|---|---|---|
| ASL MRI and MRA | Experimental | All participants will undergo ASL-MRI and MRA at three points; baseline, month 1, and month 3. Receives: Device: MRI brain; Device: ASL-MRI brain; Device: MRA brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortical cerebral blood flow (CBF) measured in ml/100g/min using ASL-MRI.
The process includes detailed imaging analysis.
Measured: Baseline, month 1, and month 3
Change in Circle of Willis arteries and major branches structure, this will be assessed by MRA and examined by a neuro-radiologist.
Correlation between vascular changes and perfusion levels will be measured.
Measured: Baseline, month 1, and month 3
Secondary outcomes (2)
RCVS complications, such as ischaemia, bleeding, and posterior reversible encephalopathy syndrome, will be assessed using standard MRI brain sequences.
Correlation between occurrence of these complications and perfusion levels will be measured.
Measured: Baseline, month 1, and month 3
Headache characteristics; participants will be questioned about their headache using a questionnaire as part of the case report form.
Correlation between headache characteristics and perfusion levels will be measured.
Measured: Baseline, month 1, and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Reversible Cerebral Vasoconstriction SyndromeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756416
- Sponsor's protocol ID
- 15085
- Status last verified
- Jul 2016
- First submitted
- 2 Mar 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Calabrese LH, Dodick DW, Schwedt TJ, Singhal AB. Narrative review: reversible cerebral vasoconstriction syndromes. Ann Intern Med. 2007 Jan 2;146(1):34-44. doi: 10.7326/0003-4819-146-1-200701020-00007.
PubMed 17200220Ducros A, Boukobza M, Porcher R, Sarov M, Valade D, Bousser MG. The clinical and radiological spectrum of reversible cerebral vasoconstriction syndrome. A prospective series of 67 patients. Brain. 2007 Dec;130(Pt 12):3091-101. doi: 10.1093/brain/awm256. Epub 2007 Nov 19.
PubMed 18025032Miller TR, Shivashankar R, Mossa-Basha M, Gandhi D. Reversible Cerebral Vasoconstriction Syndrome, Part 1: Epidemiology, Pathogenesis, and Clinical Course. AJNR Am J Neuroradiol. 2015 Aug;36(8):1392-9. doi: 10.3174/ajnr.A4214. Epub 2015 Jan 15.
PubMed 25593203Bernard KR, Rivera M. Reversible Cerebral Vasoconstriction Syndrome. J Emerg Med. 2015 Jul;49(1):26-31. doi: 10.1016/j.jemermed.2015.01.012. Epub 2015 Apr 7.
PubMed 25858343Sattar A, Manousakis G, Jensen MB. Systematic review of reversible cerebral vasoconstriction syndrome. Expert Rev Cardiovasc Ther. 2010 Oct;8(10):1417-21. doi: 10.1586/erc.10.124.
PubMed 20936928Lee R, Ramadan H, Bamford J. Reversible cerebral vasoconstriction syndrome. J R Coll Physicians Edinb. 2013;43(3):225-8. doi: 10.4997/JRCPE.2013.307.
PubMed 24087801Calic Z, Cappelen-Smith C, Zagami AS. Reversible cerebral vasoconstriction syndrome. Intern Med J. 2015 Jun;45(6):599-608. doi: 10.1111/imj.12669.
PubMed 25511128Mortimer AM, Bradley MD, Stoodley NG, Renowden SA. Thunderclap headache: diagnostic considerations and neuroimaging features. Clin Radiol. 2013 Mar;68(3):e101-13. doi: 10.1016/j.crad.2012.08.032. Epub 2012 Dec 11.
PubMed 23245274Dilli E. Thunderclap headache. Curr Neurol Neurosci Rep. 2014 Apr;14(4):437. doi: 10.1007/s11910-014-0437-9.
PubMed 24643327Miller TR, Shivashankar R, Mossa-Basha M, Gandhi D. Reversible Cerebral Vasoconstriction Syndrome, Part 2: Diagnostic Work-Up, Imaging Evaluation, and Differential Diagnosis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1580-8. doi: 10.3174/ajnr.A4215. Epub 2015 Jan 22.
PubMed 25614476Rosenbloom MH, Singhal AB. CT angiography and diffusion-perfusion MR imaging in a patient with ipsilateral reversible cerebral vasoconstriction after carotid endarterectomy. AJNR Am J Neuroradiol. 2007 May;28(5):920-2.
PubMed 17494670Komatsu T, Kimura T, Yagishita A, Takahashi K, Koide R. A case of reversible cerebral vasoconstriction syndrome presenting with recurrent neurological deficits: Evaluation using noninvasive arterial spin labeling MRI. Clin Neurol Neurosurg. 2014 Nov;126:96-8. doi: 10.1016/j.clineuro.2014.08.023. Epub 2014 Aug 30. No abstract available.
PubMed 25238101
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion MRI in Reversible Cerebral Vasoconstriction Syndrome
- ClinicalTrials.gov ID
- NCT02756416
- Acronym / sponsor ID
- 15085
- Keywords
- Reversible Cerebral Vasoconstriction Syndrome (RCVS), Arterial spin labeling (ASL) MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Apr 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.
This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these data at multiple time points during RCVS progression, the investigators will assess the relationship between vasoconstriction and downstream perfusion and determine the role of these imaging techniques in early and accurate diagnosis of RCVS. The investigators also aim to investigate whether early imaging abnormalities can predict RCVS complications and clinical outcomes.
Detailed description
Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a group of conditions characterised by prolonged but reversible multifocal narrowing of the cerebral arteries. It presents typically as acute severe headache, usually recurrent and thunderclap in character, with or without additional symptoms and signs. Adverse complications associated with RCVS can be devastating especially if not recognised early; depending on the degree of vasoconstriction, RCVS may be associated with cortical subarachnoid haemorrhage (in approximately 34% of patients), ischaemic infarction (6-39% of patients), or concomitant posterior reversible encephalopathy syndrome (PRES, 9-38% of patients). RCVS may also present as parenchymal brain haemorrhage in 20% of cases. The data on complications rate highlight the uncertainty about the condition and indicate need for more research to better characterise the evolution of the pathology; hence need for this study as it is prospective and longitudinal.
The hallmark of RCVS is vasoconstriction seen on vascular imaging scans and typically reverses within 3 months. Prevalence of radiological vasoconstriction seen on magnetic resonance angiography (MRA) in RCVS is reported to be between 60-90% and typically appears as diffuse segmental constriction of large and medium sized vessels lasting 4-12 weeks. The main advantage of MRA is that it can be performed without the use of a radioactive tracer, thus providing a safe method for repeat observations of vascular pathology. Imaging is often negative in first 4-5 days following the onset of headache; The mean time to detect abnormality on vascular imaging has been reported as 8 days after headache onset. RCVS symptoms usually resolves by 1 month after presentation, however the adverse complications associated with RCVS may have lasting consequences as described above. Magnetic resonance imaging (MRI) is an excellent tool for characterising brain changes during the progression and resolution of RCVS. Standard structural images can identify complications of RCVS, such as bleeding, ischaemia, and PRES.
Finally, Arterial Spin Labeling (ASL) MRI can be used to non-invasively quantify perfusion of brain tissue, providing a measure of the impact of upstream arterial vasoconstriction on local cortical regions.
Cortical perfusion has not yet been extensively studied in RCVS; at time of writing, only two case reports have been published. Rosenbloom and Singhal reported a case of RCVS induced by carotid endarterectomy following a frontal lobe ischaemic stroke. Perfusion MRI showed unilateral hypo-perfusion, mainly affecting internal watershed areas with superficial cortical regions being relatively spared. In a second study, ASL-MRI was performed on a 50-year-old man with RCVS who presented with severe recurrent headaches and neurological deficits (localising to the right hemisphere). ASL-MRI demonstrated significant hypo-perfusion in the right parieto-occipital lobe, but no infarct was seen on diffusion imaging. At 12 weeks, there was complete resolution of cerebral vasoconstriction on angiography and normal perfusion findings on ASL-MRI.
These case studies suggest that perfusion MRI can offer an additional tool to confirm and understand RCVS. ASL-MRI is a non-invasive, radiation and contrast-free technique that can be performed at multiple time points to monitor changes in perfusion over the time period of RCVS resolution and assess response to potential therapeutics.
One of the disadvantages of ASL-MRI is a low signal to noise ratio, this can be addressed by using high-field MRI at 3 Tesla (3T). In addition, 3T MRI can provide very good spatial resolution. The University of Nottingham represents one of the leading international research centres with experience in using high and ultra-high field MRI for investigating different neurological diseases such as multiple sclerosis and brain tumours with excellent results. Applying advanced non-invasive MRI techniques in this study will be a significant advantage as we investigate RCVS, understand the pathophysiology, and assess brain perfusion in multiple time points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASL MRI and MRA | Experimental | Device: MRI brain, Device: ASL-MRI brain, Device: MRA brainAll participants will undergo ASL-MRI and MRA at three points; baseline, month 1, and month 3. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female patients aged 18-60 years old
- Able to give informed written consent
- Clinical presentation suggestive of RCVS
- Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
Key exclusion criteria (5 listed)
- Evidence of brain haemorrhage or significant brain pathology on Computed Tomography (CT) scan performed as standard National Health Service (NHS) care
- Any history of significant cerebrovascular disease
- Pregnancy or breastfeeding
- MRI contraindications (e.g. metal implants or pacemaker) as indicated on the MRI Safety Screening Questionnaire
- Significant claustrophobia
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 |
|---|---|---|
| MRI brainStandard MRI brain will be performed on each participant to look at brain structure and exclude complications of RCVS (if any). | Device | ASL MRI and MRA |
| ASL-MRI brainASL-MRI is a non-contrast scan used to measure cortical cerebral blood flow (CBF) in areas supplied by major arteries (Circle of Willis). | Device | ASL MRI and MRA |
| MRA brainMR angiography scan looks at blood vessels structure. We expect to see constriction (narrowing) of the major arteries in RCVS cases. | Device | ASL MRI and MRA |
Primary outcome
Change in cortical cerebral blood flow (CBF) measured in ml/100g/min using ASL-MRI.
Time frame: Baseline, month 1, and month 3
The process includes detailed imaging analysis.
Change in Circle of Willis arteries and major branches structure, this will be assessed by MRA and examined by a neuro-radiologist.
Time frame: Baseline, month 1, and month 3
Correlation between vascular changes and perfusion levels will be measured.
2 secondary outcomes
RCVS complications, such as ischaemia, bleeding, and posterior reversible encephalopathy syndrome, will be assessed using standard MRI brain sequences.
Time frame: Baseline, month 1, and month 3
Headache characteristics; participants will be questioned about their headache using a questionnaire as part of the case report form.
Time frame: Baseline, month 1, and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 17200220Calabrese LH, Dodick DW, Schwedt TJ, Singhal AB. Narrative review: reversible cerebral vasoconstriction syndromes. Ann Intern Med. 2007 Jan 2;146(1):34-44. doi: 10.7326/0003-4819-146-1-200701020-00007.
- Background: PubMed 18025032Ducros A, Boukobza M, Porcher R, Sarov M, Valade D, Bousser MG. The clinical and radiological spectrum of reversible cerebral vasoconstriction syndrome. A prospective series of 67 patients. Brain. 2007 Dec;130(Pt 12):3091-101. doi: 10.1093/brain/awm256. Epub 2007 Nov 19.
- Background: PubMed 25593203Miller TR, Shivashankar R, Mossa-Basha M, Gandhi D. Reversible Cerebral Vasoconstriction Syndrome, Part 1: Epidemiology, Pathogenesis, and Clinical Course. AJNR Am J Neuroradiol. 2015 Aug;36(8):1392-9. doi: 10.3174/ajnr.A4214. Epub 2015 Jan 15.
- Background: PubMed 25858343Bernard KR, Rivera M. Reversible Cerebral Vasoconstriction Syndrome. J Emerg Med. 2015 Jul;49(1):26-31. doi: 10.1016/j.jemermed.2015.01.012. Epub 2015 Apr 7.
- Background: PubMed 20936928Sattar A, Manousakis G, Jensen MB. Systematic review of reversible cerebral vasoconstriction syndrome. Expert Rev Cardiovasc Ther. 2010 Oct;8(10):1417-21. doi: 10.1586/erc.10.124.
- Background: PubMed 24087801Lee R, Ramadan H, Bamford J. Reversible cerebral vasoconstriction syndrome. J R Coll Physicians Edinb. 2013;43(3):225-8. doi: 10.4997/JRCPE.2013.307.
- Background: PubMed 25511128Calic Z, Cappelen-Smith C, Zagami AS. Reversible cerebral vasoconstriction syndrome. Intern Med J. 2015 Jun;45(6):599-608. doi: 10.1111/imj.12669.
- Background: PubMed 23245274Mortimer AM, Bradley MD, Stoodley NG, Renowden SA. Thunderclap headache: diagnostic considerations and neuroimaging features. Clin Radiol. 2013 Mar;68(3):e101-13. doi: 10.1016/j.crad.2012.08.032. Epub 2012 Dec 11.
- Background: PubMed 24643327Dilli E. Thunderclap headache. Curr Neurol Neurosci Rep. 2014 Apr;14(4):437. doi: 10.1007/s11910-014-0437-9.
- Background: PubMed 25614476Miller TR, Shivashankar R, Mossa-Basha M, Gandhi D. Reversible Cerebral Vasoconstriction Syndrome, Part 2: Diagnostic Work-Up, Imaging Evaluation, and Differential Diagnosis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1580-8. doi: 10.3174/ajnr.A4215. Epub 2015 Jan 22.
- Background: PubMed 17494670Rosenbloom MH, Singhal AB. CT angiography and diffusion-perfusion MR imaging in a patient with ipsilateral reversible cerebral vasoconstriction after carotid endarterectomy. AJNR Am J Neuroradiol. 2007 May;28(5):920-2.
- Background: PubMed 25238101Komatsu T, Kimura T, Yagishita A, Takahashi K, Koide R. A case of reversible cerebral vasoconstriction syndrome presenting with recurrent neurological deficits: Evaluation using noninvasive arterial spin labeling MRI. Clin Neurol Neurosurg. 2014 Nov;126:96-8. doi: 10.1016/j.clineuro.2014.08.023. Epub 2014 Aug 30. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI brain, ASL-MRI brain and MRA brain in people with Reversible Cerebral Vasoconstriction Syndrome, run by University of Nottingham at 1 site in United Kingdom.
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 4 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 Jul 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 United Kingdom. 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 Nikos Evangelou, FRCP, D.Phil (00441159709735, nikos.evangelou@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical cerebral blood flow (CBF) measured in ml/100g/min using ASL-MRI. (time frame: Baseline, month 1, and month 3). The study lists 2 primary outcomes in all. 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 NCT02756416, which also lists 12 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 26 Jul 2016.