Arteriovenous MalformationsNCT01801488
Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm
An observational study of Arteriovenous Malformations and Intracranial Aneurysm, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Arteriovenous Malformations, Intracranial Aneurysm, Subarachnoid Hemorrhage
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2014
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to University Hospital.
Who may be able to join
- All adult patients between the ages of 18 and 89 that are having open surgical resection of an AVM or clipping of an aneurysm will be included
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.
- Medical subject headings
- Arteriovenous Malformations, 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 |
|---|---|---|
| AVM Patients | Patients receiving surgical intervention for an intracranial arterial-venous malformation. | |
| Ruptured Aneurysm | Patients receiving surgical intervention for a ruptured intracranial aneurysm. | |
| Unruptured Aneurysm | Patients receiving surgical intervention for an unruptured intracranial aneurysm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk gene expression
The samples will be frozen after collection and then analyzed.
Measured: Within one week of sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2014
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M Deshaies, MD, Principal investigator, SUNY Upstate Medical University Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801488
- Sponsor's protocol ID
- IRB#238810
- Status last verified
- Feb 2013
- First submitted
- 12 Dec 2012
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm
- ClinicalTrials.gov ID
- NCT01801488
- Acronym / sponsor ID
- IRB#238810
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2014 (actual)
- First posted
- 28 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.
Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVM Patients | – | –Patients receiving surgical intervention for an intracranial arterial-venous malformation. |
| Ruptured Aneurysm | – | –Patients receiving surgical intervention for a ruptured intracranial aneurysm. |
| Unruptured Aneurysm | – | –Patients receiving surgical intervention for an unruptured intracranial aneurysm. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to University Hospital.
Key inclusion criteria (1 listed)
- All adult patients between the ages of 18 and 89 that are having open surgical resection of an AVM or clipping of an aneurysm will be included
Key exclusion criteria (0 listed)
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
Risk gene expression
Time frame: Within one week of sample collection.
The samples will be frozen after collection and then analyzed.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
Eric M Deshaies, MD principal investigator
SUNY Upstate Medical University Neurosurgery
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 Arteriovenous Malformations and Intracranial Aneurysm, run by State University of New York - Upstate Medical University 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 0 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 25 Nov 2015. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Risk gene expression (time frame: Within one week of sample collection.). 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 25 Nov 2015.