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NCT Number: NCT03023449

Diffuse Optical Monitoring With Inhaled Nitric Oxide

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

nitric oxide

Drug

Inhaled Nitric Oxide gas

Other names: iNO, NO2

Primary outcomes

  1. Change in cerebral blood flow during the administration of iNO

    Time frame: Conclusion of the 35 minute protocol

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Steven Messe

Other

Collaborators

  • Mallinckrodt

Registry information

Acronym: DOMINO

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Jan 18, 2017
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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