- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03150524
RCVS: The Rational Approach to Diagnosis and Treatment
Study Overview
Status
Detailed Description
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, United States, 21210
- Johns Hopkins Bayview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patients 18 years of age or greater meeting the following inclusion criteria adapted from Singhal and colleagues 2 will be included:
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 **
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nimodipine
Patients in group one will receive short-acting nimodipine every 4 hours.
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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.
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.
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Active Comparator: Verapamil ER
Patients in group two will receive long-acting verapamil every 12 hours.
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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.
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 long acting verapamil every 12 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak TCD velocities
Time Frame: daily from admission to discharge (approx 5-7 days)
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Peak mean Cerebral Blood Flow velocity (CBFV) in anterior circulation vessels (MCA/Anterior Cerebral Artery (ACA)/Posterior Cerebral Artery (PCA)/internal carotid)
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daily from admission to discharge (approx 5-7 days)
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Duration of elevated TCD velocities
Time Frame: daily from admission to discharge (approx 5-7 days)
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Duration of elevated velocity (number of days from presentation to normalization/reduction)
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daily from admission to discharge (approx 5-7 days)
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Normalization of TCD velocities
Time Frame: daily from admission to discharge (approx 5-7 days)
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Normalization/reduction of velocity (yes/no)
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daily from admission to discharge (approx 5-7 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak pain score
Time Frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
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Peak pain score- Likert scale evaluating headache: 0-10 points
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every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
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Days to pain resolution
Time Frame: every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
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Number of days to resolution
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every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up
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New or recurrent stroke/hemorrhage
Time Frame: daily through hospitalization (approx 5-7 days)
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evaluated by neurological examinations and confirmed by imaging
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daily through hospitalization (approx 5-7 days)
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Modified Rankin Scale
Time Frame: on hospital discharge and at 90 day follow-up
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functional outcome scale based on mobility and ability to perform activities of daily living- scale 0-6 points (0-2 considered good outcome)
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on hospital discharge and at 90 day follow-up
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Repeat neuroimaging
Time Frame: at 90 day follow-up
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repeat neuroimaging to confirm reversibility of vasculopathy
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at 90 day follow-up
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Medication compliance
Time Frame: daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up
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ability to tolerate and adhere to medication
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daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elisabeth B Marsh, MD, Johns Hopkins University
- Principal Investigator: Rafael H Llinas, MD, Johns Hopkins University
Publications and helpful links
General Publications
- Singhal AB, Hajj-Ali RA, Topcuoglu MA, Fok J, Bena J, Yang D, Calabrese LH. Reversible cerebral vasoconstriction syndromes: analysis of 139 cases. Arch Neurol. 2011 Aug;68(8):1005-12. doi: 10.1001/archneurol.2011.68. Epub 2011 Apr 11.
- Marsh EB, Ziai WC, Llinas RH. The Need for a Rational Approach to Vasoconstrictive Syndromes: Transcranial Doppler and Calcium Channel Blockade in Reversible Cerebral Vasoconstriction Syndrome. Case Rep Neurol. 2016 Jul 29;8(2):161-171. doi: 10.1159/000447626. eCollection 2016 May-Aug.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00130191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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