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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up conclusion of the 35 minute protocol

Awards & highlights

DOMINO Trial 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.Check my eligibility

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.See study design

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.

DOMINO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am over 18 and have had a stroke.

Select...

I am over 18 years old.

DOMINO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ conclusion of the 35 minute protocol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~conclusion of the 35 minute protocol

This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of the 35 minute protocol for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in cerebral blood flow during the administration of iNO

Secondary outcome measures

Change in blood flow velocity as measured by TCD during iNO administration

Change in mean arterial blood pressure (MAP) during iNO administration

Duration of residual effect after cessation of iNO (time to return to baseline)

+1 more

DOMINO 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Steven MesseLead Sponsor

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,188 Total Patients Enrolled

Steven R Messe, M.D.Principal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Nitric Oxide for human use?

"While there is insufficient data to support Nitric Oxide's efficacy, Phase 2 of this trial indicates that it may be safe."

Answered by AI

Is the age limit for this clinical trial set at 25 years or younger?

"To be eligible for this particular study, applicants must be aged between 18 and 99. There are 46 clinical trials available for patients that are underage while seniors have 1066 options."

Answered by AI

Might I be able to join this clinical trial?

"This study requires 40 participants that have suffered from a stroke. These individuals must also be between the ages of 18-99 and meet the following inclusion criteria: 3. 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, 3. Ability and willingness to sign informed consent, Ability and willingness to sign informed consent."

Answered by AI

Could you please list any other experiments that have used Nitric Oxide?

"Currently, there are 24 clinical trials underway that involve the use of Nitric Oxide. Of these live trials, 9 have reached Phase 3 status. Although most of the trial locations are in Anchorage, Alaska, it is being conducted at 116 different sites around the world."

Answered by AI

How many individuals are enrolled in this clinical research?

"The clinical trial is currently recruiting patients, with the most recent information indicating that 40 individuals are needed at a single site. The trial was first posted on April 4th, 2017 and updated November 17th, 2021."

Answered by AI

Are patients still being enrolled in this research project?

"The most recent information on clinicaltrials.gov suggests that this study is still looking for 40 individuals to fill the 1 available location. The posting date was April 4th, 2017 and the 11/17/2021 update confirms that the trial is ongoing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diffuse Optical Monitoring With Inhaled Nitric Oxide

Steven Messe 2017. "Diffuse Optical Monitoring With Inhaled Nitric Oxide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03023449.

All > Stroke