Diffuse Optical Monitoring With Inhaled Nitric Oxide

NCT03023449 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 824559
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in cerebral blood flow during the administration of iNO

  Conclusion of the 35 minute protocol

Secondary Outcomes (4)

• Change in blood flow velocity as measured by TCD during iNO administration

  Conclusion of the 35 minute protocol

• Change in mean arterial blood pressure (MAP) during iNO administration

  Conclusion of the 35 minute protocol

• Time to maximum CBF effect after the introduction of iNO

  Conclusion of the 35 minute protocol

• Duration of residual effect after cessation of iNO (time to return to baseline)

  Conclusion of the 35 minute protocol

Study Arms (2)

Healthy Controls

EXPERIMENTAL

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.

Drug: Nitric Oxide

Acute Ischemic Stroke

EXPERIMENTAL

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.

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

Inhaled Nitric Oxide gas

Also known as: iNO, NO2

Acute Ischemic Stroke; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steven Messe: lead
• Mallinckrodt: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Steven R Messe, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: April 4, 2017
• Primary Completion: March 21, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)