Diffuse Optical Monitoring with Inhaled Nitric Oxide

Who is this study for? Adult stroke patients and healthy volunteers
What treatments are being studied? Nitric Oxide
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2017-04-04
Completion Date: 2025-07
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Leads: Steven Messe
Collaborators: Mallinckrodt

This content was sourced from clinicaltrials.gov