Diffuse Optical Monitoring With Inhaled Nitric Oxide "DOMINO"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Nitric Oxide Drug
    Other Names: iNO; NO2
    Intervention Desc: Inhaled Nitric Oxide gas
    ARM 1: Kind: Experimental
    Label: Healthy Controls
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Acute Ischemic Stroke
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in cerebral blood flow during the administration of iNO Conclusion of the 35 minute protocol
Secondary Change in blood flow velocity as measured by TCD during iNO administration Conclusion of the 35 minute protocol
Secondary Change in mean arterial blood pressure (MAP) during iNO administration Conclusion of the 35 minute protocol
Secondary Time to maximum CBF effect after the introduction of iNO Conclusion of the 35 minute protocol
Secondary Duration of residual effect after cessation of iNO (time to return to baseline) Conclusion of the 35 minute protocol

Sponsors