Clinical trial NCT03023449: Diffuse Optical Monitoring with Inhaled Nitric Oxide
Official title: Diffuse Optical Monitoring with Inhaled Nitric Oxide
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2017-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in cerebral blood flow during the administration of iNO
timeFrame: Conclusion of the 35 minute protocol
Secondary outcomes:
measure: Change in blood flow velocity as measured by TCD during iNO administration
timeFrame: Conclusion of the 35 minute protocol
measure: Change in mean arterial blood pressure (MAP) during iNO administration
timeFrame: Conclusion of the 35 minute protocol
measure: Time to maximum CBF effect after the introduction of iNO
timeFrame: Conclusion of the 35 minute protocol
measure: Duration of residual effect after cessation of iNO (time to return to baseline)
timeFrame: Conclusion of the 35 minute protocol
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Steven R Messe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: