Diffuse Optical Monitoring With Inhaled Nitric Oxide (DOMINO)

Steven Messe

Status and phase: Active, not recruiting; Phase 2

Conditions: Stroke

Treatments: Drug: Nitric Oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03023449

824559

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Healthy Controls

Experimental group

Description:

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.

Treatment:

Drug: Nitric Oxide

Acute Ischemic Stroke

Experimental group

Description:

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.

Treatment:

Drug: Nitric Oxide