Diffuse Optical Monitoring With Inhaled Nitric Oxide (DOMINO)

  • STATUS
    Recruiting
  • End date
    Jul 26, 2023
  • participants needed
    40
  • sponsor
    Steven Messe
Updated on 25 February 2022
ischemic stroke
Accepts healthy volunteers

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.

Details
Condition Stroke
Treatment Nitric Oxide
Clinical Study IdentifierNCT03023449
SponsorSteven Messe
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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