NCT02756416

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

March 2, 2016

Last Update Submit

July 25, 2016

Conditions

Reversible Cerebral Vasoconstriction Syndrome

Keywords

Reversible Cerebral Vasoconstriction Syndrome (RCVS)Arterial spin labeling (ASL) MRI

Outcome Measures

Primary Outcomes (2)

  • Change in cortical cerebral blood flow (CBF) measured in ml/100g/min using ASL-MRI.

    The process includes detailed imaging analysis.

    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.

    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.

    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.

    Baseline, month 1, and month 3

Study Arms (1)

ASL MRI and MRA

EXPERIMENTAL

All participants will undergo ASL-MRI and MRA at three points; baseline, month 1, and month 3.

Device: MRI brainDevice: ASL-MRI brainDevice: MRA brain

Interventions

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 and MRA
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).

ASL MRI and MRA
MRA brainDEVICE

MR angiography scan looks at blood vessels structure. We expect to see constriction (narrowing) of the major arteries in RCVS cases.

ASL MRI and MRA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (12)

  • 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.

    PMID: 17200220BACKGROUND

  • Ducros 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.

    PMID: 18025032BACKGROUND

  • Miller 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.

    PMID: 25593203BACKGROUND

  • Bernard 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.

    PMID: 25858343BACKGROUND

  • Sattar 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.

    PMID: 20936928BACKGROUND

  • Lee 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.

    PMID: 24087801BACKGROUND

  • Calic Z, Cappelen-Smith C, Zagami AS. Reversible cerebral vasoconstriction syndrome. Intern Med J. 2015 Jun;45(6):599-608. doi: 10.1111/imj.12669.

    PMID: 25511128BACKGROUND

  • Mortimer 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.

    PMID: 23245274BACKGROUND

  • Dilli E. Thunderclap headache. Curr Neurol Neurosci Rep. 2014 Apr;14(4):437. doi: 10.1007/s11910-014-0437-9.

    PMID: 24643327BACKGROUND

  • Miller 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.

    PMID: 25614476BACKGROUND

  • Rosenbloom 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.

    PMID: 17494670BACKGROUND

  • Komatsu 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.

    PMID: 25238101BACKGROUND

Central Study Contacts

Nikos Evangelou, FRCP, D.Phil

CONTACT

00441159709735nikos.evangelou@nottingham.ac.uk

Yasser Falah, MBChB, MRCP

CONTACT

00441158231082yasser.falah@nottingham.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

April 29, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

GB(1)