StrokePhase 2DOMINONCT03023449
Diffuse Optical Monitoring With Inhaled Nitric Oxide
A Phase 2 study testing Nitric Oxide in people with Stroke, run by Steven Messe at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 3. Ability and willingness to sign informed consent
- Healthy subjects:
- Age greater than 18
- Ability and willingness to sign informed consent
Who cannot join
- Stroke subjects:
- History of prior stroke or transient ischemic attack
- Known cerebrovascular abnormality
- History of congestive heart failure
- Presence of pneumonia or active pulmonary infection
- Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
Show all 29Show fewer
- Age less than 18 years
- Skull defect that would interfere with CBF monitoring
- Pregnancy
- Structural brain lesion
- Prior neurosurgical procedure
- History of psychiatric disease
- Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
- Healthy subjects:
- History of any neurological disease
- History of stroke or transient ischemic attack
- Known cerebrovascular abnormality
- History of congestive heart failure
- History of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease
- Presence of pneumonia or active pulmonary infection
- Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
- Age less than 18 years
- Skull defect that would interfere with CBF monitoring
- Pregnancy (urine or blood tests will not be performed)
- Structural brain lesion
- Prior neurosurgical procedure
- History of psychiatric disease
- Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Stroke
- Being tested
- Nitric Oxide
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called iNO, NO2
Inhaled Nitric Oxide gas
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | 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. Receives: Drug: Nitric Oxide |
| Acute Ischemic Stroke | Experimental | 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. Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow during the administration of iNO
Measured: Conclusion of the 35 minute protocol
Secondary outcomes (4)
Change in blood flow velocity as measured by TCD during iNO administration
Measured: Conclusion of the 35 minute protocol
Change in mean arterial blood pressure (MAP) during iNO administration
Measured: Conclusion of the 35 minute protocol
Time to maximum CBF effect after the introduction of iNO
Measured: Conclusion of the 35 minute protocol
Duration of residual effect after cessation of iNO (time to return to baseline)
Measured: Conclusion of the 35 minute protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start4 Apr 2017
- Primary completion21 Mar 2021
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steven Messe
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Steven Messe, University of Pennsylvania
- Investigators
- Steven R Messe, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023449
- Sponsor's protocol ID
- 824559
- Acronym
- DOMINO
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2017
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffuse Optical Monitoring With Inhaled Nitric Oxide
- ClinicalTrials.gov ID
- NCT03023449
- Acronym / sponsor ID
- DOMINO / 824559
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Steven MesseUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Drug: Nitric OxideThe 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. |
| Acute Ischemic Stroke | Experimental | Drug: Nitric OxidePatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Age greater than 18
Key exclusion criteria (29 listed)
- History of prior stroke or transient ischemic attack
- Known cerebrovascular abnormality
- History of congestive heart failure
- Presence of pneumonia or active pulmonary infection
- Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: iNO, NO2Inhaled Nitric Oxide gas | Drug | Acute Ischemic Stroke, Healthy Controls |
Primary outcome
Change in cerebral blood flow during the administration of iNO
Time frame: Conclusion of the 35 minute protocol
4 secondary outcomes
Change in blood flow velocity as measured by TCD during iNO administration
Time frame: Conclusion of the 35 minute protocol
Change in mean arterial blood pressure (MAP) during iNO administration
Time frame: Conclusion of the 35 minute protocol
Time to maximum CBF effect after the introduction of iNO
Time frame: Conclusion of the 35 minute protocol
Duration of residual effect after cessation of iNO (time to return to baseline)
Time frame: Conclusion of the 35 minute protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Messe, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide in people with Stroke, run by Steven Messe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral blood flow during the administration of iNO (time frame: Conclusion of the 35 minute protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.