Brain Vascular DisordersNCT00579241
Detection of Ultrasound Contrast Signals in the Cerebral Circulation
A study testing Ultrasound on Temporal Bone in people with Brain Vascular Disorders and Coronary Artery Disease, run by University of Nebraska.
Trial summary
To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Vascular Disorders, Coronary Artery Disease
- What is being tested?
- Ultrasound on Temporal Bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2006to 12 Dec 2009
- Phase
- Interventional
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female age >19 years of age
- scheduled for a stress echocardiogram
- negative urine pregnancy test within two hours of ultrasound contrast administration required for females of childbearing age unless post-menopausal or with evidence of surgical sterilization
- be conscious and coherent, and able to communicate effectively with trial personnel
Who cannot join
- pregnant or lactation
- life expectancy of less than 2 months or terminally ill
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study
- complicated hemodynamic instability
- Known left main disease
About this study
Official title: Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography
To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography.
Read the detailed description
The purpose of this study is to determine whether the intravenous microbubbles used to improve border delineation during dobutamine stress echocardiographies (DSE) can be detected within the cerebral circulation.
- Conditions
- Brain Vascular Disorders, Coronary Artery Disease
- Being tested
- Ultrasound on Temporal Bone
- Medical subject headings
- Cerebrovascular Disorders, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound on Temporal BoneProcedure or surgery
All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
| Study group | Role | What they receive |
|---|---|---|
| 1 Transcranial imaging using Doppler Ultrasound | Experimental | Transcranial imaging using Doppler ultrasound Receives: Procedure: Ultrasound on Temporal Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect abnormalities in cerebral blood flow
All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
Measured: immediate
Secondary outcomes (1)
if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.
All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
Measured: within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start27 Apr 2006
- Primary completion12 Dec 2009
- Study completion12 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Vascular DisordersStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska Medicial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579241
- Sponsor's protocol ID
- 0113-06-FB
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2007
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography
- ClinicalTrials.gov ID
- NCT00579241
- Acronym / sponsor ID
- 0113-06-FB
- Conditions
- Brain Vascular Disorders, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 27 Apr 2006 (actual)
- Primary completion
- 12 Dec 2009 (actual)
- Study completion
- 12 Dec 2009 (actual)
- First posted
- 24 Dec 2007 (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.
To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography.
Detailed description
The purpose of this study is to determine whether the intravenous microbubbles used to improve border delineation during dobutamine stress echocardiographies (DSE) can be detected within the cerebral circulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Transcranial imaging using Doppler Ultrasound | Experimental | Procedure: Ultrasound on Temporal BoneTranscranial imaging using Doppler ultrasound |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female age >19 years of age
- scheduled for a stress echocardiogram
- negative urine pregnancy test within two hours of ultrasound contrast administration required for females of childbearing age unless post-menopausal or with evidence of surgical sterilization
- be conscious and coherent, and able to communicate effectively with trial personnel
Key exclusion criteria (5 listed)
- pregnant or lactation
- life expectancy of less than 2 months or terminally ill
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study
- complicated hemodynamic instability
- Known left main disease
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 |
|---|---|---|
| Ultrasound on Temporal BoneAll Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur. | Procedure or surgery | 1 Transcranial imaging using Doppler Ultrasound |
Primary outcome
Detect abnormalities in cerebral blood flow
Time frame: immediate
All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.
1 secondary outcome
if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.
Time frame: within 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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.
Thomas R Porter, MD principal investigator
University of Nebraska Medicial Center
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound on Temporal Bone in people with Brain Vascular Disorders and Coronary Artery Disease, run by University of Nebraska.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Detect abnormalities in cerebral blood flow (time frame: immediate). 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 23 Sep 2024.