Nitric Oxide for Stroke

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hospital of the University of Pennsylvania, Philadelphia, PA
Stroke
Nitric Oxide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether inhaled nitric oxide may help improve blood flow to the brain for individuals with acute ischemic stroke.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Nitric Oxide will improve 1 primary outcome and 4 secondary outcomes in patients with Stroke. Measurement will happen over the course of Conclusion of the 35 minute protocol.

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

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Acute Ischemic Stroke
1 of 2
Healthy Controls
1 of 2
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nitric Oxide is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Acute Ischemic Stroke
Drug
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.
Healthy Controls
Drug
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: conclusion of the 35 minute protocol
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly conclusion of the 35 minute protocol for reporting.

Closest Location

Hospital of the University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
Ability and willingness to sign informed consent

Patient Q&A Section

What causes stroke?

"There is a wide diversity of environmental and genetic factors that contribute to the occurrence of stroke. This is important because the use of specific medications and risk factors can reduce both fatal and non-fatal stroke occurrences. Current treatments, especially for the prevention of second and third strokes, are not well supported by scientific evidence. In general, the aim of preventive medicine is to reduce the risk of stroke through strategies that lower blood pressure or use of medications to prevent blood sugar from rising too high. However, further research is needed to study the exact risks and effective preventive strategies of all stroke types." - Anonymous Online Contributor

Unverified Answer

What are the signs of stroke?

"There are many important points in the body of evidence that show that there are several clinical signs that are strongly associated with stroke. There is strong evidence that the initial clinical signs of stroke can be seen almost simultaneously with the onset of a ischemic stroke. The time of onset of a stroke appears to be important for identification of the underlying mechanism. There is also evidence that in patients that have had a stroke before they show any symptoms it is also important to look at what is happening to the brain of those not having had a stroke. It is also evident that specific clinical signs of stroke appear before specific areas of the body are affected. For example, loss of vision and speech may be found before loss of limbs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for stroke?

"Most stroke events are treated by a combination of treatments, although most treatments are often not used, with their individual efficacy, side effects or cost/cost considerations. There is a need for a review of standard treatment algorithms." - Anonymous Online Contributor

Unverified Answer

What is stroke?

"Stroke is a disorder characterized by a sudden loss of brain function, usually due to a blood clot occluding the blood vessels of the brain. About 62.4% of strokes are due to a blood clot blocking one of the blood vessels leading to the brain while 42.6% are a complication of a previous stroke. Most strokes are the result of a blood clot occluding an artery that supplies the brain-stem and/or the brain with oxygen. Most strokes are related to problems occurring in the heart or blood vessels." - Anonymous Online Contributor

Unverified Answer

How many people get stroke a year in the United States?

"About 80,000 people develop a first stroke, and approximately 46,000 of these will be recurrence and major strokes in the year following the index stroke. The vast majority of strokes are ischemic but there is an emerging proportion of strokes caused by vascular lesions or, more rarely, arterial embolism. Stroke due to arterial embolism is a relatively uncommon cause of recurrent ischaemic stroke." - Anonymous Online Contributor

Unverified Answer

Can stroke be cured?

"Even very early stroke rehabilitation might have a beneficial effect on the neurological outcome. Stroke is a devastating disease. It is an irreversible condition because stroke is usually triggered by long-term, and very high risk factors. Early intervention is very important because it allows to halt or reverse the deterioration into a permanent neurological deficit in most patients." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets stroke?

"The average age of stroke patients is 58.3 years. Stroke patients are more likely to be female, black or African American, and have hypertension. After adjusting for demographic factors, stroke severity increases per decade in patients." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating stroke?

"The latest studies have a promising outlook of treatments in progress. At least two therapies have some positive results. This is an area where future research needs to be directed and more emphasis more seriously be given." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nitric oxide for therapeutic use?

"Nitric oxide has promising therapeutic implications for acute strokes and for acute/subacute myocardial infarction when administered in appropriate doses and for long-term cardiovascular disease when used in conjunction with traditional cardiovascular risk factors." - Anonymous Online Contributor

Unverified Answer

Is nitric oxide safe for people?

"Despite NO being important in the formation of NO in the lungs, the results suggest that nitric oxide is not harmful for healthy people. Results from a recent clinical trial were also the case when nitric oxide was added to a sterile blood-containing solution. The NO concentration in such solutions was in the range of that observed in blood plasma. This leads us to believe that the NO concentrations in both the human airways and lungs are probably too high to be toxic to the airway or lung function." - Anonymous Online Contributor

Unverified Answer

Does stroke run in families?

"Stroke related familial pattern in the three generations of our family in the Indian population can be due to a complex interaction of genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nitric oxide?

"This preliminary study confirms the potential value of NO in acute stroke as well as the positive effects of NO on neurological outcome. However, further study is needed with a larger number of patients to ensure that positive results are statistically significant." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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