StrokeNCT00282841
Visualization of Cerebral Arteries Using Contrast-Enhanced Transcranial Ultrasound in Stroke Patients
A study testing ultrasound in people with Stroke, run by University of California, San Diego at 2 sites in United States.
Trial summary
The purpose of this study is to find out more about the usefulness of ultrasound in combination with a contrast solution to look for blood vessel blockage or occlusion in the brains of stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Oct 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient 18 years of age or older
- code stroke patient
Who cannot join
- women with positive pregnancy test
- women who are breast feeding
- severe emphysema
- pulmonary vasculitis
- history of pulmonary emboli
- chronic renal failure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego Hillcrest Medical Center
San Diego, California, 92101
Sharp Memorial Hospital, 7901 Frost Street
San Diego, California, 92103-8756
About this study
Official title: Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients
The purpose of this study is to find out more about the usefulness of ultrasound in combination with a contrast solution to look for blood vessel blockage or occlusion in the brains of stroke patients.
Read the detailed description
Ischemic stroke is a common, devastating and costly disease. A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain.
The purpose of this study is to visualize the blood vessels in the brain and to look for vessel occlusion (i.e., blockage) which may be the cause of stroke. Ultrasound contrast imaging may or may not improve the ability to diagnose vessel occlusion in the brain quickly and precisely, thereby expediting the therapy currently in place for acute stroke.
The contrast solutions used in this study have been approved by the Food and Drug Administration because they improve ultrasound pictures taken in the heart. While the solutions are approved for use with ultrasound in viewing the heart, the usefulness in viewing brain vessels has not been approved and is experimental.
The study will enroll 400 participants with possible diagnosis of acute stroke. Individuals participating in the study will be injected with a contrast solution via an intravenous line. A small probe will be used to obtain images of blood vessels in the head. The study researchers will measure vital signs prior to injection of the contrast solution, 5 minutes after the injection, and at the end of the ultrasound. Each participant will have a 5-minute mental function assessment and a brief neurological exam. Participants will undergo at least 3 ultrasounds. The total time of each ultrasound is less than 30 minutes.
This study is part of the Specialized Program of Translational Research in Acute Stroke to enhance and initiate translational research that ultimately will benefit stroke patients. Results from this study may help investigators learn about the future development of new diagnostic tests for stroke.
- Conditions
- Stroke
- Being tested
- ultrasound
- Keywords
- stroke, ultrasound, occlusion, blockage, contrast solution
- Medical subject headings
- Stroke, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
Also called Doppler
single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| All stroke code patients | Experimental | After written informed consent Code Stroke patients will undergo a contrast-enhanced transcranial ultrasound study to visualize the intracranial arteries. To do so, an ultrasound contrast agent (Definity) will be administered intravenously and transcranial ultrasound will be applied via the temporal bone window on both sides. Goal is to visualize and assess the intracranial arteries bilaterally. This includes the following vessel segments on both sides: middle cerebral artery (M1,M2,M3 segments), anterior cerebral artery (A1,A2 segments), posterior cerebral artery (P1,P2 segments), internal carotid artery (C1/2,C3/4 segments). Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)
The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.
Measured: within 24 hours after reference method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startMar 2005
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Study terminated due to slow recruitment and funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Mattrey, MD, Principal investigator, UCSD Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282841
- Sponsor's protocol ID
- P50NS44148MATTREY
- Other IDs
- P50NS044148-06
- Status last verified
- Jul 2019
- First submitted
- 26 Jan 2006
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Holscher T, Sattin JA, Raman R, Wilkening W, Fanale CV, Olson SE, Mattrey RF, Lyden PD. Real-time cerebral angiography: sensitivity of a new contrast-specific ultrasound technique. AJNR Am J Neuroradiol. 2007 Apr;28(4):635-9.
PubMed 17416812
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients
- ClinicalTrials.gov ID
- NCT00282841
- Acronym / sponsor ID
- P50NS44148MATTREY
- Conditions
- Stroke
- Keywords
- stroke, ultrasound, occlusion, blockage, contrast solution
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to slow recruitment and funding ended.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out more about the usefulness of ultrasound in combination with a contrast solution to look for blood vessel blockage or occlusion in the brains of stroke patients.
Detailed description
Ischemic stroke is a common, devastating and costly disease. A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain.
The purpose of this study is to visualize the blood vessels in the brain and to look for vessel occlusion (i.e., blockage) which may be the cause of stroke. Ultrasound contrast imaging may or may not improve the ability to diagnose vessel occlusion in the brain quickly and precisely, thereby expediting the therapy currently in place for acute stroke.
The contrast solutions used in this study have been approved by the Food and Drug Administration because they improve ultrasound pictures taken in the heart. While the solutions are approved for use with ultrasound in viewing the heart, the usefulness in viewing brain vessels has not been approved and is experimental.
The study will enroll 400 participants with possible diagnosis of acute stroke. Individuals participating in the study will be injected with a contrast solution via an intravenous line. A small probe will be used to obtain images of blood vessels in the head. The study researchers will measure vital signs prior to injection of the contrast solution, 5 minutes after the injection, and at the end of the ultrasound. Each participant will have a 5-minute mental function assessment and a brief neurological exam. Participants will undergo at least 3 ultrasounds. The total time of each ultrasound is less than 30 minutes.
This study is part of the Specialized Program of Translational Research in Acute Stroke to enhance and initiate translational research that ultimately will benefit stroke patients. Results from this study may help investigators learn about the future development of new diagnostic tests for stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All stroke code patients | Experimental | Other: ultrasoundAfter written informed consent Code Stroke patients will undergo a contrast-enhanced transcranial ultrasound study to visualize the intracranial arteries. To do so, an ultrasound contrast agent (Definity) will be administered intravenously and transcranial ultrasound will be applied via the temporal bone window on both sides. Goal is to visualize and assess the intracranial arteries bilaterally. This includes the following vessel segments on both sides: middle cerebral artery (M1,M2,M3 segments), anterior cerebral artery (A1,A2 segments), posterior cerebral artery (P1,P2 segments), internal carotid artery (C1/2,C3/4 segments). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient 18 years of age or older
- code stroke patient
Key exclusion criteria (6 listed)
- women with positive pregnancy test
- women who are breast feeding
- severe emphysema
- pulmonary vasculitis
- history of pulmonary emboli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundAlso: Dopplersingle intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound. | Other | All stroke code patients |
Primary outcome
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)
Time frame: within 24 hours after reference method
The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17416812Holscher T, Sattin JA, Raman R, Wilkening W, Fanale CV, Olson SE, Mattrey RF, Lyden PD. Real-time cerebral angiography: sensitivity of a new contrast-specific ultrasound technique. AJNR Am J Neuroradiol. 2007 Apr;28(4):635-9.
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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.
Robert Mattrey, MD principal investigator
UCSD Stroke Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Stroke, run by University of California, San Diego at 2 sites 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA) (time frame: within 24 hours after reference method). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282841, which also lists 1 linked publication.
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 7 Aug 2019.