DOMINO: Diffuse Optical Monitoring With Inhaled Nitric Oxide

Sponsor
Steven Messe (Other)
Overall Status
Recruiting
CT.gov ID
NCT03023449
Collaborator
Mallinckrodt (Industry)
40
Enrollment
1
Location
2
Arms
74.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Drug: Nitric Oxide
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 4, 2017
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

ArmIntervention/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

    Primary Outcome Measures

    1. Change in cerebral blood flow during the administration of iNO [Conclusion of the 35 minute protocol]

    Secondary Outcome Measures

    1. Change in blood flow velocity as measured by TCD during iNO administration [Conclusion of the 35 minute protocol]

    2. Change in mean arterial blood pressure (MAP) during iNO administration [Conclusion of the 35 minute protocol]

    3. Time to maximum CBF effect after the introduction of iNO [Conclusion of the 35 minute protocol]

    4. Duration of residual effect after cessation of iNO (time to return to baseline) [Conclusion of the 35 minute protocol]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    4. 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

    Locations

    SiteCityStateCountryPostal Code
    1Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104

    Sponsors and Collaborators

    • Steven Messe
    • Mallinckrodt

    Investigators

    • Principal Investigator: Steven R Messe, M.D., University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven Messe, Associate Professor of Neurology, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03023449
    Other Study ID Numbers:
    • 824559
    First Posted:
    Jan 18, 2017
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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:

    Study Results

    No Results Posted as of Nov 19, 2021