Reversible Cerebral Vasoconstriction Syndrome and Varicella Zoster Virus
Palabras clave
Abstracto
Descripción
In the previous pilot study, reactivation of VZV was confirmed in 63.6% of the patients as having RCVS by cell mediated immune response (CMI) test and 18.2% by Saliva PCR. None of patients who were simply stressed showed reactivation of VZV. Considering about 20% had false negative results in angiographic findings of RCVS, we set the effect size as 0.63 in group of subjects and 0.12 in group of controls. Using alpha values of 0.05 and beta values of 0.2, we calculated the target number of the study. If the ratio of cases to controls is 1:2, 9 case-patients and 18 control-patients were needed and if the ratio is 1:3, 8 case-patients and 24 control-patients were needed. We expect to enroll 10 case-patients and 20 to 30 control-patients within two years, considering the drop rate of 10~20%.
Baseline clinical information regarding age, sex, smoking history and medical comorbidities including hypertension (treated, systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at discharge), diabetes (treated, fasting blood glucose ≥126 mg/d), hyperlipidemia (treated, total cholesterol level ≥200 mg/dl or low‐density lipoprotein level ≥140 mg/dl) and coronary artery disease will be collected on admission. Laboratory tests, including complete blood count, blood chemistry, c-reactive protein and erythrocyte sediment rate wil be performed. Images of brain MRI, MR angiography, CT angiography or digital substraction angiography will be gathered if present.
Tests for VZV specific antibody responses and T-cell mediated immune response will be performed by VZV specific ELISA and IFN-γ ELISPOT, respectively. Result for T cell responses will be shown as spot number per 10^6 PBMCs. On the day of blood sample collection, plasma will be isolated and freezed (-80℃). Peripheral mononuclear cells will be separated from the remaining blood samples and keep freezed (-190℃). Melt the frozen peripheral mononuclear cells and inoculate them on a plate (T-Track human IFN-γ, Lophius) with anti-human IFN-γ antibody and inoculate VZV lysate (Microbix) 50 ug/mL on them. After incubating 24 hours, the staining will be performed and the spot will be read in a automated ELISPOT reader (ELR07 reader system, Autoimmune Diagnostika GmbH).
For statistical analysis, patients with thunderclap headache will divided into two groups according to the presence of RCVS. Among them, the rate of infection with varicella zoster virus will be compared and analyzed. Fisher's exact test, Mann-Whitney test, Pearson correlation will be performed. Also, logistic regression analysis will be used, and covariates will be adjusted if needed. Sensitivity and specificity of tests for reactivation of VZV and RCVS will be analyzed too.
fechas
Verificado por última vez: | 07/31/2018 |
Primero enviado: | 04/16/2018 |
Inscripción estimada enviada: | 04/24/2018 |
Publicado por primera vez: | 04/25/2018 |
Última actualización enviada: | 08/27/2018 |
Última actualización publicada: | 08/28/2018 |
Fecha de inicio real del estudio: | 04/30/2018 |
Fecha estimada de finalización primaria: | 04/29/2020 |
Fecha estimada de finalización del estudio: | 04/29/2020 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: VZV-specific antibody response from blood
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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. | |
Control Patients with thunderclap headache and intracranial stenosis, but not diagnosed as RCVS. |
Criterio de elegibilidad
Edades elegibles para estudiar | 20 Years A 20 Years |
Sexos elegibles para estudiar | All |
Método de muestreo | Probability Sample |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Patients with thunderclap headache and suspicious of intracranial vascular lesion by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA). Exclusion Criteria: - 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 |
Salir
Medidas de resultado primarias
1. Infection or reactivation of varicella zoster virus (VZV) [At the time of enrolled.]