Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral BloodNCT01639534
Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
An observational study of Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood and Ischemia/Hypoperfusion of Brain, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood, Ischemia/Hypoperfusion of Brain
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 9 Oct 2013
- 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 scheduled for Carotid Stenting Procedure at Virginia Commonwealth University
Who may be able to join
- Men and Women over age of 18 non
- Women who are not pregnant
- Subject who are not prisoners
- Subjects presenting to the operation room for a Carotid artery stenting procedure
- Hemoglobin greater than or equal to 11mg/dl
- Subjects who speak english
- Subjects 18 years of age or older
Who cannot join
- Hemoglobin less than 11mg/dl
- Women who are pregnant
- Children under age of 18
- Prisoners
- Non English
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. In this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.
Read the detailed description
We will compare a new blood test with routine tests that the doctor will order as part of your normal care. This study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in your blood. This blood will be analyzed i the laboratory at Virginia Commonwealth University and possibly at a future date at another institution. No names will be associated with the blood sample
- Conditions
- Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood, Ischemia/Hypoperfusion of Brain
- Keywords
- Biomarkers of ischemia, Carotid Stenting procedure, Levels Xanthine Hypoxanthine and Inosine, peripheral blood
- Medical subject headings
- Ischemia
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 |
|---|---|---|
| Biomarkers, Carotid Stenting, Blood sample | Subjects requiring Carotid Stenting Procedure at Virginia Commonwealth University/Medical College of Virginia Health Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures
To compare a new blood test with can help the doctor determine if there is a brain injury or ischemia, The study will measure new biomarkers of neurologic stress called xanthine, hypoxanthine and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in the blood. The blood will be analyzed in the laboratory at VCU.
Measured: analysis will occur after all samples collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startMar 2011
- Primary completion9 Oct 2013
- Study completion9 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral BloodStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynne Gehr, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639534
- Sponsor's protocol ID
- HM12941
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2012
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
- ClinicalTrials.gov ID
- NCT01639534
- Acronym / sponsor ID
- HM12941
- Conditions
- Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood, Ischemia/Hypoperfusion of Brain
- Keywords
- Biomarkers of ischemia, Carotid Stenting procedure, Levels Xanthine Hypoxanthine and Inosine, peripheral blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- 9 Oct 2013 (actual)
- Study completion
- 9 Oct 2013 (actual)
- First posted
- 12 Jul 2012 (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.
The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. In this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.
Detailed description
We will compare a new blood test with routine tests that the doctor will order as part of your normal care. This study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in your blood. This blood will be analyzed i the laboratory at Virginia Commonwealth University and possibly at a future date at another institution. No names will be associated with the blood sample
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkers, Carotid Stenting, Blood sample | – | –Subjects requiring Carotid Stenting Procedure at Virginia Commonwealth University/Medical College of Virginia Health Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for Carotid Stenting Procedure at Virginia Commonwealth University
Key inclusion criteria (7 listed)
- Men and Women over age of 18 non
- Women who are not pregnant
- Subject who are not prisoners
- Subjects presenting to the operation room for a Carotid artery stenting procedure
- Hemoglobin greater than or equal to 11mg/dl
Key exclusion criteria (5 listed)
- Hemoglobin less than 11mg/dl
- Women who are pregnant
- Children under age of 18
- Prisoners
- Non English
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
Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures
Time frame: analysis will occur after all samples collected
To compare a new blood test with can help the doctor determine if there is a brain injury or ischemia, The study will measure new biomarkers of neurologic stress called xanthine, hypoxanthine and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in the blood. The blood will be analyzed in the laboratory at VCU.
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 31 Jul 2018.
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.
Lynne Gehr, MD principal investigator
Virginia Commonwealth University
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 Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood and Ischemia/Hypoperfusion of Brain, run by Virginia Commonwealth 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 7 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: finished, as of the sponsor's last update on 31 Jul 2018. 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?
Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures (time frame: analysis will occur after all samples collected). 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 31 Jul 2018.