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• W2535744322 abstract "OBJECTIVE: To investigate the safety and efficacy of NBO in AIS, using advanced MRI techniques. BACKGROUND: Rodent and pilot human studies have shown that NBO reduces diffusion-MRI (DWI) lesion growth and improves apparent-diffusion-coefficient (ADC) values in AIS. DESIGN/METHODS: tPA-ineligible subjects with DWI-confirmed AIS 4 were randomized to NBO or Room Air (RA), delivered for 8h. The presence of diffusion-perfusion (DWI/PWI) 9mismatch9 was not required for inclusion. DWI/PWI and MRA were obtained at 0h, 4h (during therapy) and 24h, and non-contrast MRI at 48h and 3mo. Analysis was blinded to therapy and timing/chronology of MRI. RESULTS: Serial MRI was obtained in n=60 subjects (NBO 29, RA 31). The NBO arm had more women (69% vs 39%, p=0.02) and shorter mean onset to MRI time (4:14 vs 5:35, p=0.01). There was no significant difference between NBO and RA arms for baseline DWI volume (50+55 vs 41+57 cc), mean transit time (MTT) lesion volume (119+95 vs 108+87 cc), DWI/MTT 9mismatch9 >30% (72% vs 79%), mean ADC values (0.620+0.15 vs 0.647+0.09), or the rates of brain hemorrhage, brain edema, FLAIR dense vessel sign, HARM sign, CSF-space hyperintensity, the site of arterial occlusion, arterial recanalization, or tissue reperfusion. There was no significant difference in the pre-specified Primary Outcome Measure for Safety (percent DWI growth from 0-48h, 123+76 vs 90+84 cc, p=0.3) or Efficacy (percent DWI growth from 0-4h, 20+31 vs 16+28 cc, p=0.7). The pre-specified automated MRI analysis of Voxel Fates showed a significant difference in the number of voxels showing transient ADC reversal by 4h i.e. during NBO (5% vs 2%, p=0.02), and no difference in the number of voxels with ADC values worsening to ischemic levels by 24h (61% vs 61%, p=0.97). CONCLUSIONS: In this trial NBO had no effect on infarct growth, however its temporal effects on voxel-based ADC values suggests efficacy and safety. Supported by: NIH-NINDS. Disclosure: Dr. Singhal has received personal compensation as an expert witness in medicolegal cases involving stroke in young adults. Dr. Singhal9s wife is an employee of Vertex Pharmaceuticals, Inc. Dr. Singhal has received research support from Pfizer and Photothera, Inc. Dr. On Behalf of Partners SPOTRIAS Investigators has nothing to disclose." @default.
• W2535744322 created "2016-10-28" @default.
• W2535744322 creator A5068460102 @default.
• W2535744322 date "2013-02-12" @default.
• W2535744322 modified "2023-09-23" @default.
• W2535744322 title "Serial MRI Findings in a Phase 2B Clinical Trial of Normobaric Oxygen Therapy (NBO) in Acute Ischemic Stroke (AIS) (IN7-2.002)" @default.
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