NCT03023449Active, not recruitingPhase 2
Diffuse Optical Monitoring With Inhaled Nitric Oxide
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Jan 2017
- Start date
- 4 Apr 2017
- Primary completion date
- 21 Mar 2021
- Lead sponsor
- Steven Messe
- Diseases
- Stroke
- NCT number
- NCT03023449
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 4 Apr 2017 to the primary completion date, 21 Mar 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior stroke or transient ischemic attack
- Prior neurosurgical procedure
- Prior neurosurgical procedure
Other illness
- Stroke subjects:
- History of congestive heart failure
- Presence of pneumonia or active pulmonary infection
- 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
- History of stroke or transient ischemic attack
- History of congestive heart failure
- History of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease
- Presence of pneumonia or active pulmonary infection
- 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
- Cognitive impairment
Lab values
- Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
- Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
Age
- Age less than 18 years
- Age less than 18 years
Other
- Known cerebrovascular abnormality
- Skull defect that would interfere with CBF monitoring
- Pregnancy
- Structural brain lesion
- Known cerebrovascular abnormality
- Skull defect that would interfere with CBF monitoring
- Pregnancy (urine or blood tests will not be performed)
- Structural brain lesion
Who the study is looking for
- 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
- 3\. Ability and willingness to sign informed consent
- Healthy subjects:
- Age greater than 18
- Ability and willingness to sign informed consent
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.