Diffuse Optical Monitoring With Inhaled Nitric Oxide (DOMINO)
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ClinicalTrials.gov Identifier: NCT03023449 |
Recruitment Status :
Recruiting
First Posted : January 18, 2017
Last Update Posted : November 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Drug: Nitric Oxide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Diffuse Optical Monitoring With Inhaled Nitric Oxide |
Actual Study Start Date : | April 4, 2017 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
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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.
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Drug: Nitric Oxide
Inhaled Nitric Oxide gas
Other Names:
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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.
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Drug: Nitric Oxide
Inhaled Nitric Oxide gas
Other Names:
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- Change in cerebral blood flow during the administration of iNO [ Time Frame: Conclusion of the 35 minute protocol ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
Exclusion Criteria:
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)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023449
Contact: Nichole Gallatti, M.S.Ed | 215-349-8651 | nichole.gallatti@uphs.upenn.edu | |
Contact: Devin M Keating | 215-662-7673 | devin.keating@uphs.upenn.edu |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Nichole Gallatti 215-349-8651 nichole.gallatti@uphs.upenn.edu | |
Principal Investigator: Steven R Messe, M.D |
Principal Investigator: | Steven R Messe, M.D. | University of Pennsylvania |
Responsible Party: | Steven Messe, Associate Professor of Neurology, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT03023449 |
Other Study ID Numbers: |
824559 |
First Posted: | January 18, 2017 Key Record Dates |
Last Update Posted: | November 19, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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