Diffuse Optical Monitoring With Inhaled Nitric Oxide

Stroke Clinical Trial

— DOMINO  

Official title:

Diffuse Optical Monitoring With Inhaled Nitric Oxide

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03023449
• Other study ID #: 824559
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 4, 2017
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Nitric Oxide
Inhaled Nitric Oxide gas

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Steven Messe	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cerebral blood flow during the administration of iNO		Conclusion of the 35 minute protocol
Secondary	Change in blood flow velocity as measured by TCD during iNO administration		Conclusion of the 35 minute protocol
Secondary	Change in mean arterial blood pressure (MAP) during iNO administration		Conclusion of the 35 minute protocol
Secondary	Time to maximum CBF effect after the introduction of iNO		Conclusion of the 35 minute protocol
Secondary	Duration of residual effect after cessation of iNO (time to return to baseline)		Conclusion of the 35 minute protocol