Stroke
Conditions
Brief summary
This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral blood flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects. The monitoring is a 35 minute session during which cerebral hemodynamics will be monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration, are continuously monitored.
Interventions
DRUGNitric Oxide
Inhaled Nitric Oxide gas
Sponsors
Mallinckrodt
Steven Messe
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Stroke Patients: 1. Age greater than 18 2. Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain 3. Study can be initiated within 72 hours of stroke symptom onset 3\. Ability and willingness to sign informed consent Healthy subjects: 1. Age greater than 18 2. Ability and willingness to sign informed consent
Exclusion criteria
Stroke subjects: 1. History of prior stroke or transient ischemic attack 2. Known cerebrovascular abnormality 3. History of congestive heart failure 4. Presence of pneumonia or active pulmonary infection 5. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin) 6. Age less than 18 years 7. Skull defect that would interfere with CBF monitoring 8. Pregnancy 9. Structural brain lesion 10. Prior neurosurgical procedure 11. History of psychiatric disease 12. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study Healthy subjects: 1. History of any neurological disease 2. History of stroke or transient ischemic attack 3. Known cerebrovascular abnormality 4. History of congestive heart failure 5. History of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease 6. Presence of pneumonia or active pulmonary infection 7. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin) 8. Age less than 18 years 9. Skull defect that would interfere with CBF monitoring 10. Pregnancy (urine or blood tests will not be performed) 11. Structural brain lesion 12. Prior neurosurgical procedure 13. History of psychiatric disease 14. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study 15. Cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cerebral blood flow during the administration of iNO | Conclusion of the 35 minute protocol |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood flow velocity as measured by TCD during iNO administration | Conclusion of the 35 minute protocol |
| Change in mean arterial blood pressure (MAP) during iNO administration | Conclusion of the 35 minute protocol |
| Time to maximum CBF effect after the introduction of iNO | Conclusion of the 35 minute protocol |
| Duration of residual effect after cessation of iNO (time to return to baseline) | Conclusion of the 35 minute protocol |
Countries
United States
Outcome results
None listed