Cerebral VasospasmNCT02389634
Identification of Novel Molecular Markers for Vasospasm
An observational study of Cerebral Vasospasm and Subarachnoid Hemorrhage, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
The purpose of the study is to identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 25 Oct 2019
- 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: Adult patients with aneurysmal subarachnoid hemorrhage
Who may be able to join
- Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed.
- Receive either open vascular clipping or endovascular coiling.
Who cannot join
- Patients under 18 years of age.
- Patients arriving at the hospital >24-hours post-hemorrhage.
- Patients who are not candidates for further care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: Identification of Novel Molecular Markers for Vasospasm From the Cerebrospinal Fluid (CSF) of Patients With Aneurysmal Subarachnoid Hemorrhage
The purpose of the study is to identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
Read the detailed description
Cerebral vasospasm is a recognized and poorly understood complication for many patients who have aneurysmal subarachnoid hemorrhage. Constriction of the cerebral arterial vasculature occurs as free subarachnoid blood under high pressure comes into contact with the surfaces of vessels, particularly in the basal cisterns. However, the exact pathophysiology of vasospasm is unknown. Morbidity and mortality rates for vasospasm are high despite improvements in management. Excluding the initial hemorrhage, cerebral vasospasm is recognized as the main cause of substantial disability and death. Cerebral vasospasm kills 7% of patients, and causes severe deficit in another 7%. Cerebral vasospasm almost never occurs before day 3, has maximal incidence at days 6-8, and rarely occurs after day 17. The disorder is clinically characterized by confusion or decreased consciousness with focal neurological deficit.
Experimental evidence suggests that red blood cell hemolysis and subsequent release of oxygen, hemoglobin, reactive oxygen species, and other as yet undescribed mediators are necessary for the development of vasospasm. The goal of this study is to use modern tools of genomics to identify novel molecular markers for the process of vasospasm by studying the release of micro ribonucleic acids (RNA) that are secreted into the cerebrospinal fluid following the initiation of vasospastic cascades. Micro RNA's have recently been identified as important regulators of many cellular processes including cell cycle progression, proliferation, tumor suppressors, oncogenes, and regulators of metabolic pathways. The researchers propose to study the levels of annotated micro RNA's in the cerebrospinal fluid (CSF) of patients who present with subarachnoid hemorrhage from presentation through the hospital stay. The researchers will correlate the level of these micro RNA's with patient clinical presentation, including transcranial Doppler measurements, Glasgow Coma Scale score, vital signs, and angiographic studies. It is well established that the process of vasospasm occurs over the course of many days. Long before vasospasm becomes clinically evident, cellular processes causing spasm are in action and the researchers hope to identify micro RNA mediators of these processes using high throughput screening methods.
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startSep 2010
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral VasospasmStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Responsible party
- Principal investigator, Lori Wood, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Robert F Spetzler, MD, Principal investigator, Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389634
- Sponsor's protocol ID
- 10BN048
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2015
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Molecular Markers for Vasospasm From the Cerebrospinal Fluid (CSF) of Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02389634
- Acronym / sponsor ID
- 10BN048
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Study start
- Sep 2010
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 17 Mar 2015 (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 identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
Detailed description
Cerebral vasospasm is a recognized and poorly understood complication for many patients who have aneurysmal subarachnoid hemorrhage. Constriction of the cerebral arterial vasculature occurs as free subarachnoid blood under high pressure comes into contact with the surfaces of vessels, particularly in the basal cisterns. However, the exact pathophysiology of vasospasm is unknown. Morbidity and mortality rates for vasospasm are high despite improvements in management. Excluding the initial hemorrhage, cerebral vasospasm is recognized as the main cause of substantial disability and death. Cerebral vasospasm kills 7% of patients, and causes severe deficit in another 7%. Cerebral vasospasm almost never occurs before day 3, has maximal incidence at days 6-8, and rarely occurs after day 17. The disorder is clinically characterized by confusion or decreased consciousness with focal neurological deficit.
Experimental evidence suggests that red blood cell hemolysis and subsequent release of oxygen, hemoglobin, reactive oxygen species, and other as yet undescribed mediators are necessary for the development of vasospasm. The goal of this study is to use modern tools of genomics to identify novel molecular markers for the process of vasospasm by studying the release of micro ribonucleic acids (RNA) that are secreted into the cerebrospinal fluid following the initiation of vasospastic cascades. Micro RNA's have recently been identified as important regulators of many cellular processes including cell cycle progression, proliferation, tumor suppressors, oncogenes, and regulators of metabolic pathways. The researchers propose to study the levels of annotated micro RNA's in the cerebrospinal fluid (CSF) of patients who present with subarachnoid hemorrhage from presentation through the hospital stay. The researchers will correlate the level of these micro RNA's with patient clinical presentation, including transcranial Doppler measurements, Glasgow Coma Scale score, vital signs, and angiographic studies. It is well established that the process of vasospasm occurs over the course of many days. Long before vasospasm becomes clinically evident, cellular processes causing spasm are in action and the researchers hope to identify micro RNA mediators of these processes using high throughput screening methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with aneurysmal subarachnoid hemorrhage
Key inclusion criteria (2 listed)
- Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed.
- Receive either open vascular clipping or endovascular coiling.
Key exclusion criteria (3 listed)
- Patients under 18 years of age.
- Patients arriving at the hospital >24-hours post-hemorrhage.
- Patients who are not candidates for further care.
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
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms
Time frame: 30 days
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms
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 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Vasospasm
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Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
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Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Recruiting
The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
RecruitingObservational study
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
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 F Spetzler, MD principal investigator
Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
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 Subarachnoid Hemorrhage, run by St. Joseph's Hospital and Medical Center, Phoenix 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 2 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 19 Apr 2024. 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?
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms (time frame: 30 days). 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 19 Apr 2024.