RCVS: The Rational Approach to Diagnosis and Treatment
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/8/2018 |
Start Date: | July 1, 2017 |
End Date: | May 31, 2019 |
Contact: | Elisabeth B Marsh, MD |
Email: | ebmarsh@jhmi.edu |
Phone: | 4105508703 |
This is a randomized clinical trial of short-acting nimodipine versus twice daily extended
release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction
Syndrome (RCVS).
release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction
Syndrome (RCVS).
Patients greater than 18 years of age presenting with clinical signs and symptoms consistent
with RCVS (see inclusion criteria) will be enrolled. Neuroimaging (CT, Magnetic Resonance
(MR), or 4 vessel angiogram) will be obtained along with a baseline transcranial doppler
ultrasound (TCD). They will subsequently be randomized to receive nimodipine (every 4 hours)
or extended release verapamil (twice daily). Mean cerebral blood flow velocities will be
followed for reduction or normalization on daily TCD and medication dosing adjusted
appropriately. Patients will be followed 90 days post-discharge at which time they will
undergo repeat neuroimaging to confirm resolution of vascular abnormalities and repeat
evaluation. To determine effectiveness, the investigators will evaluate both short-term
(surrogate) in-hospital outcomes and long-term outcomes. Reduction of TCD velocities and
headache severity will serve as our short-term surrogate outcomes; however, need for
additional medications, blood pressure, new/recurrent stroke/Intracranial Hemorrhage (ICH)
will also be evaluated along with modified Rankin score (mRS) on discharge, length of stay,
and discharge disposition. At 90 days, the investigators will also assess headache control
along with mRS.. Adverse events and their relation to the treatment arms will be assessed,
and adherence to the medications will be evaluated.
with RCVS (see inclusion criteria) will be enrolled. Neuroimaging (CT, Magnetic Resonance
(MR), or 4 vessel angiogram) will be obtained along with a baseline transcranial doppler
ultrasound (TCD). They will subsequently be randomized to receive nimodipine (every 4 hours)
or extended release verapamil (twice daily). Mean cerebral blood flow velocities will be
followed for reduction or normalization on daily TCD and medication dosing adjusted
appropriately. Patients will be followed 90 days post-discharge at which time they will
undergo repeat neuroimaging to confirm resolution of vascular abnormalities and repeat
evaluation. To determine effectiveness, the investigators will evaluate both short-term
(surrogate) in-hospital outcomes and long-term outcomes. Reduction of TCD velocities and
headache severity will serve as our short-term surrogate outcomes; however, need for
additional medications, blood pressure, new/recurrent stroke/Intracranial Hemorrhage (ICH)
will also be evaluated along with modified Rankin score (mRS) on discharge, length of stay,
and discharge disposition. At 90 days, the investigators will also assess headache control
along with mRS.. Adverse events and their relation to the treatment arms will be assessed,
and adherence to the medications will be evaluated.
Patients 18 years of age or greater meeting the following inclusion criteria adapted from
Singhal and colleagues 2 will be included:
1. presentation consistent with RCVS :
- acute thunderclap/severe headache and
**supporting clinical features should prompt increased clinical suspicion (eg.,
potential medication trigger, recent pregnancy, migraine history)**
- evidence of beading/elevated velocities on imaging (Transcranial Doppler (TCD),
angiogram, Computer Tomography Angiogram (CTA), MRA) and
- reversibility (by 90 days)-will not be required for inclusion but will be
retrospectively adjudicated
Participants will be excluded from the study if they are:
- unable to consent AND no family present to consent, or
- have presence of aneurysmal, traumatic, or mesencephalic Subarachnoid Hemorrhage
(SAH), or
- have presence of other supported diagnosis (eg., vasculitis- inflammatory lumbar
puncture) or
- are currently pregnant or
- the use of nimodipine or verapamil is contraindicated for any reason (eg., allergy,
breast feeding) or
- have limited TCD sonographic window
- stroke or ICH/SAH on presentation will not be a contraindication to inclusion in
the trial **
We found this trial at
2
sites
4940 Eastern Ave
Baltimore, Maryland 21224
Baltimore, Maryland 21224
(410) 550-0100
Phone: 410-550-8703
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