Abstract Details

Title Serial MRI Findings in a Phase 2B Clinical Trial of Normobaric Oxygen Therapy (NBO) in Acute Ischemic Stroke (AIS)

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) S41 - (-)

Poster/Presentation
Number 001

Objective

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<9h and NIHSS>4 were randomized to NBO or Room Air (RA), delivered for 8h. The presence of diffusion-perfusion (DWI/PWI) 'mismatch' 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 'mismatch' >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.

Authors/Disclosures
Aneesh B. Singhal, MD, FAAN (Massachusetts General Hospital) PRESENTER	An immediate family member of Dr. Singhal has received personal compensation for serving as an employee of Biogen. Dr. Singhal has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Medicolegal Firms. Dr. Singhal has received research support from NIH-NINDS. Dr. Singhal has received publishing royalties from a publication relating to health care. Dr. Singhal has received publishing royalties from a publication relating to health care. Dr. Singhal has received personal compensation in the range of $500-$4,999 for serving as a Honorarium (��ɫ��) with Biogen.
	No disclosure on file
	No disclosure on file

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