Acute Arterial Ischemic StrokeNCT01786785
Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke
An observational study of Acute Arterial Ischemic Stroke, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top ten causes of death in children. Currently, caregivers lay the affected child flat in hopes of increasing blood flow to the brain and reducing the volume of the brain which is damaged. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Arterial Ischemic Stroke
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 22 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children (2-18 y.o.) presenting at the Children's Hospital of Philadelphia with a confirmed arterial ischemic stroke
Who may be able to join
- Subjects age 2-18 years inclusive
- No history of congenital or acquired brain injury
- No history of developmental delay, mental retardation, genetic or metabolic syndrome affecting the brain
- Subjects age 2-18 years inclusive
- 72 hours or less from stroke onset
- MRI or CT confirmation of AIS
Who cannot join
- Skull defect preventing application of probes
- Moyamoya disease
- Sickle cell anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke: A Pilot Study
Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top ten causes of death in children. Currently, caregivers lay the affected child flat in hopes of increasing blood flow to the brain and reducing the volume of the brain which is damaged. However, there are currently no techniques to measure brain blood flow at the child's bedside and indicate if this treatment is effective. We will probe brain blood volume, oxygen saturation, and flow with red light to determine the efficacy of this intervention.
Read the detailed description
Arterial ischemic stroke (AIS) affects about 2 children per 100,000 per year and is one of the top 10 causes of mortality in children. After stroke, there is a disturbance in cerebral blood flow (CBF) autoregulation, and changes in head position may change CBF. Currently, practice at the Children's Hospital of Philadelphia (CHOP) is to keep the head of bed (HOB) of a child with AIS flat for 24 hours; however, there is no evidence that this practice is efficacious in children. Furthermore, maintaining a child supine for 24 hours is uncomfortable for the child and is often unenforceable in younger children. This study will use a noninvasive optical technique to measure CBF as HOB position is changed to assess the effectiveness of head of bed position in increasing CBF in children with acute arterial ischemic stroke.
The primary objectives are to determine the difference in CBF at HOB flat (0 degrees) and HOB at +30 degrees in healthy children and in children with AIS. The secondary objectives are to examine CBF in healthy children and in children with AIS at other HOB angles (0, +15, and +30 degrees) compared to the CBF at HOB 0 degrees and to determine if the position that maximizes CBF varies over time from stroke onset.
- Conditions
- Acute Arterial Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients | Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke. | |
| Controls | Age and Gender Matched Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in microvascular blood flow in supine position
Microvascular blood flow will be measured at 24, 48, and 72 hours post stroke, with the head of bed at 30, 15, and 0 deg (supine). Current clinical practice is to lower the head of bed to the supine position to increase blood flow.
Measured: 72 hours post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completion22 Oct 2016
- Study completion22 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Arterial Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, National Institutes of Health (NIH), Alavi-Dabiri Postdoctoral Fellowship Award, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Daniel L Licht, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786785
- Sponsor's protocol ID
- 11-008442
- Other IDs
- K12NS049453
- Status last verified
- Apr 2022
- First submitted
- 6 Feb 2013
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT01786785
- Acronym / sponsor ID
- 11-008442
- Conditions
- Acute Arterial Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, National Institutes of Health (NIH), Alavi-Dabiri Postdoctoral Fellowship Award, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2012
- Primary completion
- 22 Oct 2016 (actual)
- Study completion
- 22 Oct 2016 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top ten causes of death in children. Currently, caregivers lay the affected child flat in hopes of increasing blood flow to the brain and reducing the volume of the brain which is damaged. However, there are currently no techniques to measure brain blood flow at the child's bedside and indicate if this treatment is effective. We will probe brain blood volume, oxygen saturation, and flow with red light to determine the efficacy of this intervention.
Detailed description
Arterial ischemic stroke (AIS) affects about 2 children per 100,000 per year and is one of the top 10 causes of mortality in children. After stroke, there is a disturbance in cerebral blood flow (CBF) autoregulation, and changes in head position may change CBF. Currently, practice at the Children's Hospital of Philadelphia (CHOP) is to keep the head of bed (HOB) of a child with AIS flat for 24 hours; however, there is no evidence that this practice is efficacious in children. Furthermore, maintaining a child supine for 24 hours is uncomfortable for the child and is often unenforceable in younger children. This study will use a noninvasive optical technique to measure CBF as HOB position is changed to assess the effectiveness of head of bed position in increasing CBF in children with acute arterial ischemic stroke.
The primary objectives are to determine the difference in CBF at HOB flat (0 degrees) and HOB at +30 degrees in healthy children and in children with AIS. The secondary objectives are to examine CBF in healthy children and in children with AIS at other HOB angles (0, +15, and +30 degrees) compared to the CBF at HOB 0 degrees and to determine if the position that maximizes CBF varies over time from stroke onset.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | – | –Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke. |
| Controls | – | –Age and Gender Matched Controls |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children (2-18 y.o.) presenting at the Children's Hospital of Philadelphia with a confirmed arterial ischemic stroke
Key inclusion criteria (6 listed)
- Subjects age 2-18 years inclusive
- No history of congenital or acquired brain injury
- No history of developmental delay, mental retardation, genetic or metabolic syndrome affecting the brain
- Subjects age 2-18 years inclusive
- 72 hours or less from stroke onset
Key exclusion criteria (3 listed)
- Skull defect preventing application of probes
- Moyamoya disease
- Sickle cell anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction in microvascular blood flow in supine position
Time frame: 72 hours post stroke
Microvascular blood flow will be measured at 24, 48, and 72 hours post stroke, with the head of bed at 30, 15, and 0 deg (supine). Current clinical practice is to lower the head of bed to the supine position to increase blood flow.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Related trials for Acute Arterial Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel L Licht, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Arterial Ischemic Stroke, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in microvascular blood flow in supine position (time frame: 72 hours post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.