Assessing Brain Injury Using Portable Magnetic Resonance Imaging (MRI)

NCT05469139 | Completed FDA Device

• 1 other identifier: IRB00285716
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assess the feasibility of assessing acute brain injury using a portable low field MRI in patients on ECMO.

Conditions

Extracorporeal Membrane Oxygenation Complication; Acute Brain Injury

Outcome Measures

Primary Outcomes (1)

• Acute brain injury as assessed by head CT scan

  compare results of routinely performed head CT scans with results from a low field MRI to determine whether acute brain injury can be assessed using a low field MRI in patients with ECMO support.

  48 hours from ECMO initiation

Secondary Outcomes (4)

• prevalence of early acute brain injury as assessed by MRI scan

  24 hours from ECMO initiation

• Image Quality

  48 hours from ECMO initiation

• Impact of early detection as assessed by MRI

  48 hours from ECMO initiation

• Association of Transcranial doppler ultrasound with ischemic infarct

  48 hours from ECMO initiation

Study Arms (1)

Portable MRI group

Patients on ECMO who undergo portable MRI to assess brain injury within 24-48 hours of ECMO initiation

Diagnostic Test: Portable MRI acquisition

Interventions

Portable MRI acquisition DIAGNOSTIC_TEST

Patients on ECMO will undergo a portable MRI of the brain

Portable MRI group

Eligibility Criteria

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

Study Population

Adults patients on extracorporeal membrane oxygenation support (ECMO)

You may qualify if:

• Adults age 18 and over
• Patient supported with extracorporeal membrane oxygenation support (ECMO)
• Legally authorized representative has provided written informed consent

You may not qualify if:

• Patient has a contraindication for MRI such as:
• Implants such as pacemaker, defibrillator, implanted insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, or programmable shunt
• MRI incompatible surgical hardware such as staples, screws. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, cochlear implant
• artificial hearts or heart valves with steel parts
• metal fragments
• shrapnel
• tattoos near the eye
• permanent make-up
• steel implants
• or other irremovable ferromagnetic objects
• Patient weight is over 440 lbs (or 200kg)
• Patient has Intra Aortic Balloon Pump (IABP), Implanted Ventricular Assist Device (VAD), or Percutaneous Ventricular Assist Device
• Patient is pregnant

Sponsors & Collaborators

• Johns Hopkins University: lead
• Hyperfine: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (12)

• McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.

  PMID: 26686427 BACKGROUND

• Thiagarajan RR, Barbaro RP, Rycus PT, Mcmullan DM, Conrad SA, Fortenberry JD, Paden ML; ELSO member centers. Extracorporeal Life Support Organization Registry International Report 2016. ASAIO J. 2017 Jan/Feb;63(1):60-67. doi: 10.1097/MAT.0000000000000475.

  PMID: 27984321 BACKGROUND

• Cho SM, Canner J, Caturegli G, Choi CW, Etchill E, Giuliano K, Chiarini G, Calligy K, Rycus P, Lorusso R, Kim BS, Sussman M, Suarez JI, Geocadin R, Bush EL, Ziai W, Whitman G. Risk Factors of Ischemic and Hemorrhagic Strokes During Venovenous Extracorporeal Membrane Oxygenation: Analysis of Data From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2021 Jan 1;49(1):91-101. doi: 10.1097/CCM.0000000000004707.

  PMID: 33148951 BACKGROUND

• Cho SM, Canner J, Chiarini G, Calligy K, Caturegli G, Rycus P, Barbaro RP, Tonna J, Lorusso R, Kilic A, Choi CW, Ziai W, Geocadin R, Whitman G. Modifiable Risk Factors and Mortality From Ischemic and Hemorrhagic Strokes in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2020 Oct;48(10):e897-e905. doi: 10.1097/CCM.0000000000004498.

  PMID: 32931195 BACKGROUND

• Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.

  PMID: 26472994 BACKGROUND

• Cho SM, Ziai W, Mayasi Y, Gusdon AM, Creed J, Sharrock M, Stephens RS, Choi CW, Ritzl EK, Suarez J, Whitman G, Geocadin RG. Noninvasive Neurological Monitoring in Extracorporeal Membrane Oxygenation. ASAIO J. 2020 Apr;66(4):388-393. doi: 10.1097/MAT.0000000000001013.

  PMID: 31045914 BACKGROUND

• Sheth KN, Mazurek MH, Yuen MM, Cahn BA, Shah JT, Ward A, Kim JA, Gilmore EJ, Falcone GJ, Petersen N, Gobeske KT, Kaddouh F, Hwang DY, Schindler J, Sansing L, Matouk C, Rothberg J, Sze G, Siner J, Rosen MS, Spudich S, Kimberly WT. Assessment of Brain Injury Using Portable, Low-Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients. JAMA Neurol. 2020 Sep 8;78(1):41-7. doi: 10.1001/jamaneurol.2020.3263. Online ahead of print.

  PMID: 32897296 BACKGROUND

• Campbell-Washburn AE, Ramasawmy R, Restivo MC, Bhattacharya I, Basar B, Herzka DA, Hansen MS, Rogers T, Bandettini WP, McGuirt DR, Mancini C, Grodzki D, Schneider R, Majeed W, Bhat H, Xue H, Moss J, Malayeri AA, Jones EC, Koretsky AP, Kellman P, Chen MY, Lederman RJ, Balaban RS. Opportunities in Interventional and Diagnostic Imaging by Using High-Performance Low-Field-Strength MRI. Radiology. 2019 Nov;293(2):384-393. doi: 10.1148/radiol.2019190452. Epub 2019 Oct 1.

  PMID: 31573398 BACKGROUND

• Formica D, Silvestri S. Biological effects of exposure to magnetic resonance imaging: an overview. Biomed Eng Online. 2004 Apr 22;3:11. doi: 10.1186/1475-925X-3-11.

  PMID: 15104797 BACKGROUND

• Hartwig V, Giovannetti G, Vanello N, Lombardi M, Landini L, Simi S. Biological effects and safety in magnetic resonance imaging: a review. Int J Environ Res Public Health. 2009 Jun;6(6):1778-98. doi: 10.3390/ijerph6061778. Epub 2009 Jun 10.

  PMID: 19578460 BACKGROUND

• Shellock FG, Crues JV. Aneurysm clips: assessment of magnetic field interaction associated with a 0.2-T extremity MR system. Radiology. 1998 Aug;208(2):407-9. doi: 10.1148/radiology.208.2.9680568.

  PMID: 9680568 BACKGROUND

• Alorainy IA, Albadr FB, Abujamea AH. Attitude towards MRI safety during pregnancy. Ann Saudi Med. 2006 Jul-Aug;26(4):306-9. doi: 10.5144/0256-4947.2006.306. No abstract available.

  PMID: 16885635 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sung Min Cho, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: December 10, 2021
• Primary Completion: November 30, 2023
• Study Completion: March 11, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)