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Vasodilator

Inhaled Nitric Oxide for Stroke (DOMINO Trial)

Phase 2

Waitlist Available

Led By Steven R Messe, M.D.

Research Sponsored by Steven Messe

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stroke Patients: Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain

Stroke Patients: Age greater than 18

Must not have

Stroke subjects: Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)

Stroke subjects: Age less than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is measuring the cerebral blood flow response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Inhaling nitric oxide may cause side effects such as headaches, dizziness, or changes in blood pressure. Continuous monitoring will help track any immediate reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am over 18 and have had a stroke.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 18 and have had a stroke.

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

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I have a known brain blood vessel abnormality.

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I have a brain lesion due to a stroke.

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I have had brain surgery before.

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I have a known brain blood vessel abnormality.

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

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I have never had a neurological disease.

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I currently have pneumonia or another lung infection.

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I am currently taking medication that releases nitric oxide.

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I have had congestive heart failure in the past.

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

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I have had a stroke or a transient ischemic attack.

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I do not have any brain lesions.

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I have had a brain surgery in the past.

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I have pneumonia or an active lung infection.

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I have a history of heart failure.

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I am under 18 years old and healthy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitric Oxide

2004

Completed Phase 4

~1280

0 / 22Eligibility criteria met