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The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).
A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIPS monitoring group | The study population will consist of adult patients presenting for evaluation of acute brain pathology, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPS Monitoring | Diagnostic Test | Bioimpedance asymmetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemispheric bioimpedance asymmetry detection | The primary outcome will be the device's ability to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in a population of patients presenting with symptoms consistent with AIS | At the time of VIPS monitoring - day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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Males and females, aged 18 years or older, who are undergoing evaluation for acute ischemic stroke
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyerly Baptist, Inc | Jacksonville | Florida | 32207 | United States | ||
| University of Buffalo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19834014 | Background | Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15. | |
| 27781037 | Background |
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| Buffalo |
| New York |
| 14203 |
| United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Nogueira RG, Zaidat OO, Castonguay AC, Haussen DC, Martin CO, Holloway WE, Mueller-Kronast N, English J, Linfante I, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Nguyen TN, Taqi MA, Abraham MG, Janardhan V, Yoo AJ, Shaltoni H, Abou-Chebl A, Chen PR, Britz GW, Novakovic R, Nanda A, Kaushal R, Issa MA, Frankel MR, Gupta R. Rescue Thrombectomy in Large Vessel Occlusion Strokes Leads to Better Outcomes than Intravenous Thrombolysis Alone: A 'Real World' Applicability of the Recent Trials. Interv Neurol. 2016 Sep;5(3-4):101-110. doi: 10.1159/000445809. Epub 2016 May 27. |
| 26898852 | Background | Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18. |
| 27673305 | Background | Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647. |
| 27743926 | Background | Kodankandath TV, Wright P, Power PM, De Geronimo M, Libman RB, Kwiatkowski T, Katz JM. Improving Transfer Times for Acute Ischemic Stroke Patients to a Comprehensive Stroke Center. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):192-195. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.008. Epub 2016 Oct 12. |
| 23370205 | Background | Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31. |
| 27272487 | Background | Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7. |
| 27028362 | Background | John S, Stock S, Masaryk T, Bauer A, Cerejo R, Uchino K, Winners S, Rasmussen P, Hussain MS. Performance of CT Angiography on a Mobile Stroke Treatment Unit: Implications for Triage. J Neuroimaging. 2016 Jul;26(4):391-4. doi: 10.1111/jon.12346. Epub 2016 Mar 30. |
| 18544824 | Background | Rojas R, Rubinsky B, Gonzalez CA. The effect of brain hematoma location on volumetric inductive phase shift spectroscopy of the brain with circular and magnetron sensor coils: a numerical simulation study. Physiol Meas. 2008 Jun;29(6):S255-66. doi: 10.1088/0967-3334/29/6/S22. Epub 2008 Jun 11. |
| 26842606 | Background | Zuckerman SL, Sivaganesan A, Zhang C, Dewan MC, Morone PJ, Ganesh Kumar N, Mocco J. Maximizing efficiency and diagnostic accuracy triage of acute stroke patients: A case-control study. Interv Neuroradiol. 2016 Jun;22(3):304-9. doi: 10.1177/1591019915622167. Epub 2016 Feb 2. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D006470 | Hemorrhage |
| D020767 | Intracranial Thrombosis |
| D013345 | Subarachnoid Hemorrhage |
| D002544 | Cerebral Infarction |
| D002543 | Cerebral Hemorrhage |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002542 | Intracranial Embolism and Thrombosis |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D020300 | Intracranial Hemorrhages |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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