RCVS: The Rational Approach to Diagnosis and Treatment

Recruiting

Phase 4 Results N/A

Trial Description

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 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.

Conditions

Interventions

  • Nimodipine (NimotopĀ®)Drug
    Intervention Desc: Participants will be administered nimodipine every 4 hours.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
  • Transcranial doppler monitoring of cerebral blood flow velocities Diagnostic Test
    Intervention Desc: Participants will undergo daily TCD for monitoring of cerebral blood flow.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
    ARM 2: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.
  • Headache pain score Behavioral
    Intervention Desc: Participants will be evaluated by nurses for headache frequency and severity every shift.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
    ARM 2: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.
  • Neurological examination Other
    Intervention Desc: Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
    ARM 2: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.
  • Repeat Neuroimaging Diagnostic Test
    Intervention Desc: All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
    ARM 2: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.
  • Verapamil ER Drug
    Intervention Desc: Participants will be administered long acting verapamil every 12 hours.
    ARM 1: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.
  • TCD- cerebral blood flow velocities Diagnostic Test
    Intervention Desc: Participants will undergo daily TCD for monitoring of cerebral blood flow.
    ARM 1: Kind: Experimental
    Label: Nimodipine
    Description: Patients in group one will receive short-acting nimodipine every 4 hours.
    ARM 2: Kind: Experimental
    Label: Verapamil ER
    Description: Patients in group two will receive long-acting verapamil every 12 hours.

Outcomes

Type Measure Time Frame Safety Issue
Primary TCD velocities daily from admission to discharge (approx 5-7 days)
Secondary Pain score every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
Secondary New or recurrent stroke/hemorrhage daily through hospitalization (approx 5-7 days)
Secondary Modified Rankin Scale on hospital discharge and at 90 day follow-up
Secondary Repeat neuroimaging at 90 day follow-up
Secondary Medication compliance daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up
Primary Peak TCD velocities daily from admission to discharge (approx 5-7 days)
Primary Duration of elevated TCD velocities daily from admission to discharge (approx 5-7 days)
Primary Normalization of TCD velocities daily from admission to discharge (approx 5-7 days)
Secondary Peak pain score every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
Secondary Days to pain resolution every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up

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