دورية أكاديمية
Prospective randomized trial of venous angioplasty in MS (PREMiSe).
| العنوان: | Prospective randomized trial of venous angioplasty in MS (PREMiSe). |
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| المؤلفون: | Siddiqui AH; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY. asiddiqui@ubns.com rzivadinov@bnac.net., Zivadinov R; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY. asiddiqui@ubns.com rzivadinov@bnac.net., Benedict RH; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Karmon Y; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Yu J; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Hartney ML; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Marr KL; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Valnarov V; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Kennedy CL; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Ramanathan M; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Ramasamy DP; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Dolic K; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Hojnacki DW; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Carl E; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Levy EI; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Hopkins LN; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY., Weinstock-Guttman B; From the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY. |
| المصدر: | Neurology [Neurology] 2014 Jul 29; Vol. 83 (5), pp. 441-9. Date of Electronic Publication: 2014 Jun 27. |
| نوع المنشور: | Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0401060 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1526-632X (Electronic) Linking ISSN: 00283878 NLM ISO Abbreviation: Neurology Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: Minneapolis. |
| مواضيع طبية MeSH: | Angioplasty/*methods , Multiple Sclerosis/*diagnosis , Multiple Sclerosis/*therapy , Venous Insufficiency/*diagnosis , Venous Insufficiency/*therapy, Adult ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Multiple Sclerosis/epidemiology ; Prospective Studies ; Venous Insufficiency/epidemiology |
| مستخلص: | Objective: We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) with findings of extracranial venous anomalies, considered hallmarks of chronic cerebrospinal venous insufficiency (CCSVI), in a 2-phase study (ClinicalTrials.gov NCT01450072). Methods: Phase 1 was an open-label safety study (10 patients); phase 2 was sham-controlled, randomized, and double-blind (10 sham procedure, 9 treated). All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI. Assessment was at 1, 3, and 6 months postprocedure with MRI, clinical, and hemodynamic outcomes. Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life. Results: No perioperative complications were noted; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as nonsignificant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow-up. No differences in other endpoints were detected. Conclusion: Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity. Classification of Evidence: This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure. (© 2014 American Academy of Neurology.) |
| التعليقات: | Erratum in: Neurology. 2014 Aug 19;83(8):773. Comment in: Neurology. 2014 Jul 29;83(5):388-9. (PMID: 24975856) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT01450072 |
| تواريخ الأحداث: | Date Created: 20140701 Date Completed: 20140923 Latest Revision: 20211021 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC4132574 |
| DOI: | 10.1212/WNL.0000000000000638 |
| PMID: | 24975855 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1526-632X |
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| DOI: | 10.1212/WNL.0000000000000638 |