RCVS: The Rational Approach to Diagnosis and Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-05-31

Brief Summary

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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).

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Detailed Description

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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

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Reversible Cerebral Vasoconstriction Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimodipine

Patients in group one will receive short-acting nimodipine every 4 hours.

Group Type ACTIVE_COMPARATOR

TCD- cerebral blood flow velocities

Intervention Type DIAGNOSTIC_TEST

Participants will undergo daily TCD for monitoring of cerebral blood flow.

Headache pain score

Intervention Type BEHAVIORAL

Participants will be evaluated by nurses for headache frequency and severity every shift.

Neurological examination

Intervention Type OTHER

Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.

Repeat Neuroimaging

Intervention Type DIAGNOSTIC_TEST

All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.

Nimodipine

Intervention Type DRUG

Participants will be administered nimodipine every 4 hours.

Verapamil ER

Patients in group two will receive long-acting verapamil every 12 hours.

Group Type ACTIVE_COMPARATOR

TCD- cerebral blood flow velocities

Intervention Type DIAGNOSTIC_TEST

Participants will undergo daily TCD for monitoring of cerebral blood flow.

Headache pain score

Intervention Type BEHAVIORAL

Participants will be evaluated by nurses for headache frequency and severity every shift.

Neurological examination

Intervention Type OTHER

Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.

Repeat Neuroimaging

Intervention Type DIAGNOSTIC_TEST

All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.

Verapamil ER

Intervention Type DRUG

Participants will be administered long acting verapamil every 12 hours.

Interventions

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TCD- cerebral blood flow velocities

Participants will undergo daily TCD for monitoring of cerebral blood flow.

Intervention Type DIAGNOSTIC_TEST

Headache pain score

Participants will be evaluated by nurses for headache frequency and severity every shift.

Intervention Type BEHAVIORAL

Neurological examination

Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.

Intervention Type OTHER

Repeat Neuroimaging

All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.

Intervention Type DIAGNOSTIC_TEST

Nimodipine

Participants will be administered nimodipine every 4 hours.

Intervention Type DRUG

Verapamil ER

Participants will be administered long acting verapamil every 12 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 \*\*

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No