Diffuse Optical Monitoring With Inhaled Nitric Oxide
Overview
- Phase
- Phase 2
- Intervention
- Nitric Oxide
- Conditions
- Stroke
- Sponsor
- Steven Messe
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in cerebral blood flow during the administration of iNO
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Steven Messe
Associate Professor of Neurology
University of Pennsylvania
Eligibility Criteria
Inclusion Criteria
- •Stroke Patients:
- •Age greater than 18
- •Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain
- •Study can be initiated within 72 hours of stroke symptom onset
- •Ability and willingness to sign informed consent
- •Healthy subjects:
- •Age greater than 18
- •Ability and willingness to sign informed consent
Exclusion Criteria
- •Stroke subjects:
- •History of prior stroke or transient ischemic attack
- •Known cerebrovascular abnormality
- •History of congestive heart failure
- •Presence of pneumonia or active pulmonary infection
- •Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
- •Age less than 18 years
- •Skull defect that would interfere with CBF monitoring
- •Structural brain lesion
- •Prior neurosurgical procedure
Arms & Interventions
Healthy Controls
The protocol will be a 35-minute monitoring session, during which cerebral hemodynamics will be monitored with both DCS and TCD, while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide concentration, are continuously monitored. 5 minutes of baseline hemodynamics will be assessed, after which the subject will breath iNO for 5 minutes, followed by 5 minutes of room air. This iNO/room air cycle will be repeated with a total of 3 different iNO concentrations. The full protocol will require 35 minutes. Subjects will be called at 24 hours after the monitoring session to determine any tolerability issues or adverse events.
Intervention: Nitric Oxide
Acute Ischemic Stroke
Patients will be enrolled in the study within 72 hours of stroke symptom onset. The protocol will be a 35-minute monitoring session, during which cerebral hemodynamics will be monitored with both DCS and TCD, while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide concentration, are continuously monitored. 5 minutes of baseline hemodynamics will be assessed, after which the subject will breath iNO for 5 minutes, followed by 5 minutes of room air. This iNO/room air cycle will be repeated with a total of 3 different iNO concentrations. The full protocol will require 35 minutes. Subjects will be undergo a final assessment at 24 hours after the monitoring session to determine any tolerability issues or adverse events.
Intervention: Nitric Oxide
Outcomes
Primary Outcomes
Change in cerebral blood flow during the administration of iNO
Time Frame: Conclusion of the 35 minute protocol
Secondary Outcomes
- 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)