Diffuse Optical Monitoring With Inhaled Nitric Oxide

NCT ID: NCT03023449

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2026-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Controls

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.

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

Inhaled Nitric Oxide gas

Acute Ischemic Stroke

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.

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

Inhaled Nitric Oxide gas

Interventions

Nitric Oxide

Inhaled Nitric Oxide gas

Intervention Type: DRUG

Other Intervention Names

iNO; NO2

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Steven Messe

OTHER

Sponsor Role: lead

Responsible Party

Steven Messe

Associate Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven R Messe, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

824559

Identifier Type: -

Identifier Source: org_study_id