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临床试验/NCT03150524
NCT03150524撤回4 期

RCVS: The Rational Approach to Diagnosis and Treatment

Johns Hopkins University2 个研究点 分布在 1 个国家开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Peak TCD velocities

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Nimodipine

Active Comparator

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

干预措施: Neurological examination (Other)

Nimodipine

Active Comparator

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

干预措施: TCD- cerebral blood flow velocities (Diagnostic Test)

Nimodipine

Active Comparator

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

干预措施: Headache pain score (Behavioral)

Nimodipine

Active Comparator

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

干预措施: Repeat Neuroimaging (Diagnostic Test)

Nimodipine

Active Comparator

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

干预措施: Nimodipine (Drug)

Verapamil ER

Active Comparator

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

干预措施: TCD- cerebral blood flow velocities (Diagnostic Test)

Verapamil ER

Active Comparator

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

干预措施: Headache pain score (Behavioral)

Verapamil ER

Active Comparator

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

干预措施: Neurological examination (Other)

Verapamil ER

Active Comparator

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

干预措施: Repeat Neuroimaging (Diagnostic Test)

Verapamil ER

Active Comparator

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

干预措施: Verapamil ER (Drug)

结局指标

主要结局

Peak TCD velocities

时间窗: 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)

Duration of elevated TCD velocities

时间窗: daily from admission to discharge (approx 5-7 days)

Duration of elevated velocity (number of days from presentation to normalization/reduction)

Normalization of TCD velocities

时间窗: daily from admission to discharge (approx 5-7 days)

Normalization/reduction of velocity (yes/no)

次要结局

  • Modified Rankin Scale(on hospital discharge and at 90 day follow-up)
  • Medication compliance(daily throughout hospitalization (approx 5-7 days) and at 90 day follow-up)
  • Peak pain score(every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up)
  • Repeat neuroimaging(at 90 day follow-up)
  • Days to pain resolution(every 8 hours while hospitalized (approx 5-7 days) and at 90 day follow-up)
  • New or recurrent stroke/hemorrhage(daily through hospitalization (approx 5-7 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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