Clinical Trial: Perfusion MRI in Reversible Cerebral Vasoconstriction Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Perfusion MRI in Reversible Cerebral Vasoconstriction Syndrome

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.

Detailed Summary:

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 excelle
Sponsor: University of Nottingham

Current 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]
  Correlation between occurrence of these complications and perfusion levels will be measured.
• 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 ]
  Correlation between headache characteristics and perfusion levels will be measured.

Original Secondary Outcome:

• RCVS complications, such as ishaemia, bleeding, and posterior reversible encephalopathy syndrome, will be assessed using standard MRI brain sequences. [ Time Frame: Baseline, month 1, and month 3 ]
  Correlation between occurrence of these complications and perfusion levels will be measured.
• 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 ]
  Correlation between headache characteristics and perfusion levels will be measured.

Information By: University of Nottingham

Dates:
Date Received: March 2, 2016
Date Started: July 2016
Date Completion: May 2017
Last Updated: July 25, 2016
Last Verified: July 2016