Cerebral VasospasmNCT00962546
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
An observational study of Cerebral Vasospasm and Cerebral Aneurysm, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vasospasm, Cerebral Aneurysm, Subarachnoid Hemorrhage
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the neurological intensive care unit with subarachnoid hemorrhage due to rupture of a cerebral aneurysm
Who may be able to join
- subarachnoid hemorrhage after aneurysm rupture
Who cannot join
- renal insufficiency
- pregnancy
- contrast reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computed Tomographic Perfusion and Computed Tomographic Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.
- Keywords
- cerebral aneurysm, subarachnoid hemorrhage, cerebral vasospasm, computed tomographic perfusion, computed tomographic angiography
- Medical subject headings
- Vasospasm, Intracranial, Intracranial Aneurysm, Subarachnoid Hemorrhage
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 |
|---|---|---|
| CTA/CTP | Patients undergo CTA/CTP imaging prior to cerebral angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT perfusion parameters
Measured: at time of catheter angiogram
Secondary outcomes (2)
Disposition at discharge
Measured: At time of hospital discharge
vessel narrowing by CT angiography
Measured: at time of catheter angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Miller-Thomas, MD, Washington University School of Medicine
- Investigators
- Michelle Miller-Thomas, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962546
- Sponsor's protocol ID
- HRPO 09-0950
- Status last verified
- Dec 2014
- First submitted
- 19 Aug 2009
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wintermark M, Ko NU, Smith WS, Liu S, Higashida RT, Dillon WP. Vasospasm after subarachnoid hemorrhage: utility of perfusion CT and CT angiography on diagnosis and management. AJNR Am J Neuroradiol. 2006 Jan;27(1):26-34.
PubMed 16418351Aralasmak A, Akyuz M, Ozkaynak C, Sindel T, Tuncer R. CT angiography and perfusion imaging in patients with subarachnoid hemorrhage: correlation of vasospasm to perfusion abnormality. Neuroradiology. 2009 Feb;51(2):85-93. doi: 10.1007/s00234-008-0466-7. Epub 2008 Oct 11.
PubMed 18850093Mustonen T, Koivisto T, Vanninen R, Hanninen T, Vapalahti M, Hernesniemi J, Kuikka JT, Vanninen E. Heterogeneity of cerebral perfusion 1 week after haemorrhage is an independent predictor of clinical outcome in patients with aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2008 Oct;79(10):1128-33. doi: 10.1136/jnnp.2007.142851. Epub 2008 Mar 20.
PubMed 18356250
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomographic Perfusion and Computed Tomographic Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00962546
- Acronym / sponsor ID
- HRPO 09-0950
- Keywords
- cerebral aneurysm, subarachnoid hemorrhage, cerebral vasospasm, computed tomographic perfusion, computed tomographic angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Aug 2009 (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.
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure. Computed tomographic perfusion imaging (CTP) and computed tomographic angiography (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct. The investigators hypothesize that CTP and CTA may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTA/CTP | – | –Patients undergo CTA/CTP imaging prior to cerebral angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the neurological intensive care unit with subarachnoid hemorrhage due to rupture of a cerebral aneurysm
Key inclusion criteria (1 listed)
- subarachnoid hemorrhage after aneurysm rupture
Key exclusion criteria (3 listed)
- renal insufficiency
- pregnancy
- contrast reaction
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
CT perfusion parameters
Time frame: at time of catheter angiogram
2 secondary outcomes
Disposition at discharge
Time frame: At time of hospital discharge
vessel narrowing by CT angiography
Time frame: at time of catheter angiogram
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 9 Dec 2014.
- Results publication: PubMed 16418351Wintermark M, Ko NU, Smith WS, Liu S, Higashida RT, Dillon WP. Vasospasm after subarachnoid hemorrhage: utility of perfusion CT and CT angiography on diagnosis and management. AJNR Am J Neuroradiol. 2006 Jan;27(1):26-34.
- Results publication: PubMed 18850093Aralasmak A, Akyuz M, Ozkaynak C, Sindel T, Tuncer R. CT angiography and perfusion imaging in patients with subarachnoid hemorrhage: correlation of vasospasm to perfusion abnormality. Neuroradiology. 2009 Feb;51(2):85-93. doi: 10.1007/s00234-008-0466-7. Epub 2008 Oct 11.
- Results publication: PubMed 18356250Mustonen T, Koivisto T, Vanninen R, Hanninen T, Vapalahti M, Hernesniemi J, Kuikka JT, Vanninen E. Heterogeneity of cerebral perfusion 1 week after haemorrhage is an independent predictor of clinical outcome in patients with aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2008 Oct;79(10):1128-33. doi: 10.1136/jnnp.2007.142851. Epub 2008 Mar 20.
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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.
Michelle Miller-Thomas, MD principal investigator
Washington University School of Medicine
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 Cerebral Vasospasm and Cerebral Aneurysm, run by Washington University School of Medicine 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 1 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 9 Dec 2014. 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?
CT perfusion parameters (time frame: at time of catheter angiogram). 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 NCT00962546, which also lists 3 linked publications.
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 9 Dec 2014.