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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Participants will undergo daily TCD for monitoring of cerebral blood flow.
Participants will be evaluated by nurses for headache frequency and severity every shift.
Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Peak TCD velocities
Peak mean Cerebral Blood Flow velocity (CBFV) in anterior circulation vessels (MCA/Anterior Cerebral Artery (ACA)/Posterior Cerebral Artery (PCA)/internal carotid)
Time frame: daily from admission to discharge (approx 5-7 days)
Duration of elevated TCD velocities
Duration of elevated velocity (number of days from presentation to normalization/reduction)
Time frame: daily from admission to discharge (approx 5-7 days)
Normalization of TCD velocities
Normalization/reduction of velocity (yes/no)
Time frame: daily from admission to discharge (approx 5-7 days)
Peak pain score
Peak pain score- Likert scale evaluating headache: 0-10 points
Time frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
Days to pain resolution
Number of days to resolution
Time frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
New or recurrent stroke/hemorrhage
evaluated by neurological examinations and confirmed by imaging
Time frame: daily through hospitalization (approx 5-7 days)
Modified Rankin Scale
functional outcome scale based on mobility and ability to perform activities of daily living- scale 0-6 points (0-2 considered good outcome)
Time frame: on hospital discharge and at 90 day follow-up
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All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.
Participants will be administered nimodipine every 4 hours.
Participants will be administered long acting verapamil every 12 hours.
Repeat neuroimaging
repeat neuroimaging to confirm reversibility of vasculopathy
Time frame: at 90 day follow-up
Medication compliance
ability to tolerate and adhere to medication
Time frame: daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up