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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 28, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Steven Messe, University of Pennsylvania

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Nitric Oxide Phase 2

Study Design
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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 : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Nitric Oxide
Inhaled Nitric Oxide gas
Other Names:
  • iNO
  • NO2
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.
 Drug: Nitric Oxide
Inhaled Nitric Oxide gas
Other Names:
  • iNO
  • NO2


Outcome Measures
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Primary Outcome Measures :
  1. Change in cerebral blood flow during the administration of iNO [ Time Frame: Conclusion of the 35 minute protocol ]

Secondary Outcome Measures :
  1. Change in blood flow velocity as measured by TCD during iNO administration [ Time Frame: Conclusion of the 35 minute protocol ]
  2. Change in mean arterial blood pressure (MAP) during iNO administration [ Time Frame: Conclusion of the 35 minute protocol ]
  3. Time to maximum CBF effect after the introduction of iNO [ Time Frame: Conclusion of the 35 minute protocol ]
  4. Duration of residual effect after cessation of iNO (time to return to baseline) [ Time Frame: Conclusion of the 35 minute protocol ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

Stroke Patients:

  1. Age greater than 18
  2. Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain
  3. Study can be initiated within 72 hours of stroke symptom onset

3. Ability and willingness to sign informed consent

Healthy subjects:

  1. Age greater than 18
  2. Ability and willingness to sign informed consent

Exclusion Criteria:

Stroke subjects:

  1. History of prior stroke or transient ischemic attack
  2. Known cerebrovascular abnormality
  3. History of congestive heart failure
  4. Presence of pneumonia or active pulmonary infection
  5. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
  6. Age less than 18 years
  7. Skull defect that would interfere with CBF monitoring
  8. Pregnancy
  9. Structural brain lesion
  10. Prior neurosurgical procedure
  11. History of psychiatric disease
  12. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study

Healthy subjects:

  1. History of any neurological disease
  2. History of stroke or transient ischemic attack
  3. Known cerebrovascular abnormality
  4. History of congestive heart failure
  5. History of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease
  6. Presence of pneumonia or active pulmonary infection
  7. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
  8. Age less than 18 years
  9. Skull defect that would interfere with CBF monitoring
  10. Pregnancy (urine or blood tests will not be performed)
  11. Structural brain lesion
  12. Prior neurosurgical procedure
  13. History of psychiatric disease
  14. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
  15. Cognitive impairment
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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

Locations
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         
Sponsors and Collaborators
Steven Messe
Mallinckrodt
Investigators
Principal Investigator: Steven R Messe, M.D. University of Pennsylvania
More Information
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Responsible Party: Steven Messe, Associate Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03023449     History of Changes
Other Study ID Numbers: 824559
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
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

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents