Inhaled Nitric Oxide for Stroke (DOMINO Trial)

Recruiting in Palo Alto (17 mi)

Overseen BySteven R Messe, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Steven Messe

No Placebo Group

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults over 18 who've had a stroke in certain areas of the brain and can start the study within 72 hours of their stroke symptoms starting. They must be able to understand and agree to participate by signing an informed consent.

Inclusion Criteria

I had a stroke affecting the front, middle, or back part of my brain.

I am over 18 and have had a stroke.

I am over 18 years old.

Exclusion Criteria

I am currently taking medication that releases nitric oxide for my stroke.

I am under 18 and have had a stroke.

I have had a stroke or a transient ischemic attack before.

I have a known brain blood vessel abnormality.

I have a brain lesion due to a stroke.

I have had brain surgery before.

I have a known brain blood vessel abnormality.

I have a long-term lung condition like asthma or COPD.

I have never had a neurological disease.

I currently have pneumonia or another lung infection.

I am currently taking medication that releases nitric oxide.

I have had congestive heart failure in the past.

I have a skull defect that affects blood flow monitoring in my brain.

I have had a stroke or a transient ischemic attack.

I do not have any brain lesions.

I have had a brain surgery in the past.

I have pneumonia or an active lung infection.

I have a history of heart failure.

I am under 18 years old and healthy.

Participant Groups

The trial tests how breathing in nitric oxide affects blood flow in the brain after a stroke, using special monitoring techniques like DCS and TCD during a single 35-minute session.

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

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.

Group II: Acute Ischemic StrokeExperimental Treatment1 Intervention

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.

Nitric Oxide is already approved in United States, United States, United States for the following indications:

🇺🇸 Approved in United States as Inomax for: