Reversible Cerebral Vasoconstriction Syndrome and Varicella Zoster Virus

NCT03509701 | Unknown DMC

• 1 other identifier: 2018-0385
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Among patients with thunderclap headache who were admitted to the four participating hospitals, who has diffuse segmental vasoconstriction on CT angiography or MR angiography will be eligible for the study. Participants who meet the definition of RCVS will be enrolled as the case-patients and others will be enrolled as control-patients. The RCVS group will be defined when two or more neurologists agree by the clinical features and angiographic findings. The result of tests for varicella zoster virus titer will not be opened to neurologists until the end of the study. For case and control patients, tests for varicella zoster virus infection are (1) Pre-existing virological markers (ex. VZV-IgG, IgM, and VZV PCR in CSF or Skin lesion if present) (2) VZV-specific cell mediated immune response (CMI) at the time of admission and one month later (3) VZV in blood measured by quantitative test of viral load with real-time PCR and digital PCR for latent viral load (4) Quantitative test of viral load with real-time PCR in saliva at time of admission and one month later. Reactivation or infection of VZV of patients with RCVS and controls will be compared.

Conditions

Reversible Cerebral Vasoconstriction Syndrome; Varicella-zoster Virus Infection

Keywords

Reversible cerebral vasoconstriction syndrome; Herpes zoster; Varicella-zoster virus infection

Outcome Measures

Primary Outcomes (1)

• Infection or reactivation of varicella zoster virus (VZV)

  Compare prevalence of infection or reactivation of VZV in case-patients and control-patients.

  At the time of enrolled.

Study Arms (2)

Subject (RCVS)

Patients who meet the definition of RCVS. (1) acute and severe headache with or without focal deficits or seizures, (2) uniphasic course without new symptoms more than 1 month after clinical onset, (3) segmental vasoconstriction of cerebral arteries shown by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or transfemoral cerebral angiography (TFCA),(4) normal or near normal cerebrospinal fluid analysis and (5) complete or substantial normalisation of arteries shown by follow-up angiography within 12 weeks.

Diagnostic Test: VZV-specific antibody response from blood

Control

Patients with thunderclap headache and intracranial stenosis, but not diagnosed as RCVS.

Diagnostic Test: VZV-specific antibody response from blood

Interventions

VZV-specific antibody response from blood DIAGNOSTIC_TEST

Check VZV-specific antibody response, VZV specific T-cell mediated immune response by IFN-γ ELISPOT assay from blood, and real-time PCR results from saliva

Also known as: VZV-specific T cell response from blood, viral load from saliva

Control; Subject (RCVS)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who visited Asan medical center, Hanyang University Guri Hospital, Nowon Eulji Medical Center, or Kangbuk Samsung Hospital.

You may qualify if:

• Patients with thunderclap headache and suspicious of intracranial vascular lesion by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA).

You may not qualify if:

• Patients with life threatening medical condition
• Pregnant or scheduled for pregnancy
• Unwilling or unable to give informed consent
• Patients who confirmed vasculitis
• Patients with genetic disease for vascular disorder

Sponsors & Collaborators

• Asan Medical Center: lead
• Hanyang University: collaborator
• Eulji University Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

RECRUITING

Related Publications (10)

• 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.

  PMID: 21482916 BACKGROUND

• Katz BS, Fugate JE, Ameriso SF, Pujol-Lereis VA, Mandrekar J, Flemming KD, Kallmes DF, Rabinstein AA. Clinical worsening in reversible cerebral vasoconstriction syndrome. JAMA Neurol. 2014 Jan;71(1):68-73. doi: 10.1001/jamaneurol.2013.4639.

  PMID: 24190097 BACKGROUND

• Miller TR, Shivashankar R, Mossa-Basha M, Gandhi D. Reversible Cerebral Vasoconstriction Syndrome, Part 1: Epidemiology, Pathogenesis, and Clinical Course. AJNR Am J Neuroradiol. 2015 Aug;36(8):1392-9. doi: 10.3174/ajnr.A4214. Epub 2015 Jan 15.

  PMID: 25593203 BACKGROUND

• Cuvinciuc V, Viguier A, Calviere L, Raposo N, Larrue V, Cognard C, Bonneville F. Isolated acute nontraumatic cortical subarachnoid hemorrhage. AJNR Am J Neuroradiol. 2010 Sep;31(8):1355-62. doi: 10.3174/ajnr.A1986. Epub 2010 Jan 21.

  PMID: 20093311 BACKGROUND

• Kwon SU, Yun SC, Kim MC, Kim BJ, Lee SH, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH. Risk of stroke and transient ischaemic attack after herpes zoster. Clin Microbiol Infect. 2016 Jun;22(6):542-8. doi: 10.1016/j.cmi.2016.03.003. Epub 2016 Mar 16.

  PMID: 26992774 BACKGROUND

• Kim MC, Yun SC, Lee HB, Lee PH, Lee SW, Choi SH, Kim YS, Woo JH, Kim SH, Kwon SU. Herpes Zoster Increases the Risk of Stroke and Myocardial Infarction. J Am Coll Cardiol. 2017 Jul 11;70(2):295-296. doi: 10.1016/j.jacc.2017.05.015. No abstract available.

  PMID: 28683973 BACKGROUND

• Bartynski WS, Boardman JF, Zeigler ZR, Shadduck RK, Lister J. Posterior reversible encephalopathy syndrome in infection, sepsis, and shock. AJNR Am J Neuroradiol. 2006 Nov-Dec;27(10):2179-90.

  PMID: 17110690 BACKGROUND

• Park SY, Kim JY, Kim JA, Kwon JS, Kim SM, Jeon NY, Kim MC, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH. Diagnostic Usefulness of Varicella-Zoster Virus Real-Time Polymerase Chain Reaction Analysis of DNA in Saliva and Plasma Specimens From Patients With Herpes Zoster. J Infect Dis. 2017 Dec 27;217(1):51-57. doi: 10.1093/infdis/jix508.

  PMID: 29029120 BACKGROUND

• Yancy H, Lee-Iannotti JK, Schwedt TJ, Dodick DW. Reversible cerebral vasoconstriction syndrome. Headache. 2013 Mar;53(3):570-6. doi: 10.1111/head.12040.

  PMID: 23489219 BACKGROUND

• Ducros A. Reversible cerebral vasoconstriction syndrome. Lancet Neurol. 2012 Oct;11(10):906-17. doi: 10.1016/S1474-4422(12)70135-7.

  PMID: 22995694 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva

MeSH Terms

Conditions

Varicella Zoster Virus Infection; Herpes Zoster

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Sung-Han Kim, MD.Phd

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Han Kim, MD.PhD

CONTACT

82-2-3010-3305; kimsunghanmd@hotmail.com

Hyuk Sung Kwon, MD

CONTACT

82-31-560-2078; kwonhs@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 26, 2018
• Study Start: May 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)