RCVS: The Rational Approach to Diagnosis and Treatment

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Johns Hopkins University
Updated on 8 November 2020
Investigator
Elisabeth B Marsh, MD
Primary Contact
Johns Hopkins Bayview Medical Center (9.3 mi away) Contact

Summary

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).

Description

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.

Details
Treatment TCD- cerebral blood flow velocities, Headache pain score, Neurological examination, Neurological examination, Repeat Neuroimaging, Nimodipine, Nimodipine, Verapamil ER
Clinical Study IdentifierNCT03150524
SponsorJohns Hopkins University
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Reversible Cerebral Vasoconstriction Syndrome?
adapted from Singhal and colleagues 2 will be included
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
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