Clinical Trial: RCVS: The Rational Approach to Diagnosis and Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: RCVS: The Rational Approach to Diagnosis and Treatment

Brief 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).

Detailed Summary: 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.
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • TCD velocities [ Time Frame: daily from admission to discharge (approx 5-7 days) ]
    Peak mean Cerebral Blood Flow velocity (CBFV) in anterior circulation vessels (MCA/Anterior Cerebral Artery (ACA)/Posterior Cerebral Artery (PCA)/internal carotid)
  • TCD velocities [ Time Frame: daily from admission to discharge (approx 5-7 days) ]
    Duration of elevated velocity (number of days from presentation to normalization/reduction)
  • TCD velocities [ Time Frame: daily from admission to discharge (approx 5-7 days) ]
    Normalization/reduction of velocity (yes/no)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain score [ Time Frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up ]
    Peak pain score
  • Pain score [ Time Frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up ]
    Number of days to resolution
  • New or recurrent stroke/hemorrhage [ Time Frame: daily through hospitalization (approx 5-7 days) ]
    evaluated by neurological examinations and confirmed by imaging
  • Modified Rankin Scale [ Time Frame: on hospital discharge and at 90 day follow-up ]
    functional outcome scale
  • Repeat neuroimaging [ Time Frame: at 90 day follow-up ]
    repeat neuroimaging to confirm reversibility of vasculopathy
  • Medication compliance [ Time Frame: daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up ]
    ability to tolerate and adhere to medication


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: May 8, 2017
Date Started: June 1, 2017
Date Completion: May 31, 2019
Last Updated: May 9, 2017
Last Verified: May 2017