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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Inhaled Nitric Oxide gas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral blood flow during the administration of iNO | Conclusion of the 35 minute protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood flow velocity as measured by TCD during iNO administration | Conclusion of the 35 minute protocol | |
| Change in mean arterial blood pressure (MAP) during iNO administration | Conclusion of the 35 minute protocol |
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Inclusion Criteria:
Stroke Patients:
3. Ability and willingness to sign informed consent
Healthy subjects:
Exclusion Criteria:
Stroke subjects:
Healthy subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Messe, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 11, 2025 | Sep 30, 2025 | 11 | ||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| Time to maximum CBF effect after the introduction of iNO | Conclusion of the 35 minute protocol |
| Duration of residual effect after cessation of iNO (time to return to baseline) | Conclusion of the 35 minute protocol |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |