Cerebrovascular DiseasesNCT02910180
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
An observational study of Cerebrovascular Diseases and Ischemic Stroke, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Diseases, Ischemic Stroke, Repository
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients diagnosed with cerebrovascular disease. This includes both non-surgical patients (such medically managed ischemic stroke, aneurysms, moyamoya disease, arteriovenous malformation, hemorrhagic stroke, etc.) and surgically treated patients (patients with aneurysm coiling or clipping, arteriovenous malformation resection, direct or indirect revascularization procedures for ischemia, etc.).
Who may be able to join
- All patients diagnosed with cerebral vascular disease, regardless of gender, age, ethnicity/race, stage of disease or treatment, are eligible.
- Expected availability of clinical follow up data
- Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines.
Who cannot join
- Pregnant women are excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Nestor R Gonzalez, MD, MSCR, 310-423-0783, Nestor.Gonzalez@cshs.org
Antoinette Anderson, BS, (310) 423-0783, antoinette.anderson@cshs.org
About this study
This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This is a prospective observational study which will use samples from such patients to create this library which can be used to explore these questions in the future.
Read the detailed description
Genetic and metabolic profiling has become an important means to evaluate various pathologies, their effects on patients, and their treatments. In regards to cerebrovascular disease and stroke, there are a number of hypotheses which have been proposed. The levels and types of various angiogenic factors in the blood and tissues have been proposed to be predictive of patient outcome after ischemic stroke and treatment for stroke. Likewise, genetic factors may predict outcome or response to various types of treatments.
The role of biological samples in furthering our understandings about cerebrovascular disease and treatment are well documented. Muscle microdialysis samples have confirmed the presence of sublethal ischemia during the induction of remote ischemic preconditioning. The effects of remote ischemic preconditioning on the coagulation profile, DNA methylation, and cell cycle gene expression of patients with aneurysmal subarachnoid hemorrhage have also been elucidated. Blood samples collected in patients with intracranial arterial stenosis have produced many insights. Inflammatory cell profiles in patient who receive encephaloduroarteriosynangiosis (EDAS) surgery have been characterized. Angiogenic factor measurements have been shown to predict the degree of neovascularization in patients post-EDAS. In patients with intracranial atherosclerosis, angiogenic factor profiles were found to strongly correlate with failure of medical management and poor outcomes.
It is clear that genetic and metabolic profiling are effective tools in evaluating the effects of cerebrovascular disease and their treatments. This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. For every patient enrolled in the study, relevant patient information such as age, gender, diagnosis, medical history, family history, procedures/treatments received, radiological reports, and patient outcomes are recorded. This information is updated upon every follow-up during the study. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples.
Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This repository serves as the groundwork to explore these questions in the future.
- Conditions
- Cerebrovascular Diseases, Ischemic Stroke, Repository
- Keywords
- Tissue Repository, Cerebrovascular Diseases, Stroke, Aneurysm, Arteriovenous malformation, Fistula, Intracranial Stenosis, Treatment, Registry, Outcomes
- Medical subject headings
- Cerebrovascular Disorders, Ischemic Stroke, Stroke, Aneurysm, Arteriovenous Malformations, Fistula
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 |
|---|---|---|
| Repository Group | The Repository Group consists of patients which have donated tissue to the repository. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Rankin Scale (mRS) score
Measured: Baseline, 1 Month, 3 Months, and 6 Months
Change in NIH Stroke Scale score
Measured: Baseline, 1 Month, 3 Months, and 6 Months
Change in Barthel Index
Measured: Baseline, 1 Month, 3 Months, and 6 Months
Change in Montreal Cognitive Assessment test score
Measured: Baseline, 1 Month, 3 Months, and 6 Months
Secondary outcomes (2)
Change in Angiographic Neovascularization
Analyzed in digital subtraction angiography (DSA) images
Measured: Baseline and 6 Months
Change in Angiogenic Factor Measurements
Measured in blood, CSF, microdialysis samples, and tissue
Measured: Baseline, 1 Month, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor R. Gonzalez, MD, MSCR., Cedars-Sinai Medical Center
- Investigators
- Nestor R Gonzalez, MD, MSCR, Principal investigator, Cedars-Sinai Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910180
- Sponsor's protocol ID
- Pro00045392
- Status last verified
- Feb 2023
- First submitted
- 14 Sep 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Mayor F, Bilgin-Freiert A, Connolly M, Katsnelson M, Dusick JR, Vespa P, Koch S, Gonzalez NR. Effects of remote ischemic preconditioning on the coagulation profile of patients with aneurysmal subarachnoid hemorrhage: a case-control study. Neurosurgery. 2013 Nov;73(5):808-15; discussion 815. doi: 10.1227/NEU.0000000000000098.
PubMed 23867300Nikkola E, Laiwalla A, Ko A, Alvarez M, Connolly M, Ooi YC, Hsu W, Bui A, Pajukanta P, Gonzalez NR. Remote Ischemic Conditioning Alters Methylation and Expression of Cell Cycle Genes in Aneurysmal Subarachnoid Hemorrhage. Stroke. 2015 Sep;46(9):2445-51. doi: 10.1161/STROKEAHA.115.009618. Epub 2015 Aug 6.
PubMed 26251247Ooi YC, Laiwalla AN, Liou R, Gonzalez NR. Angiographic Structural Differentiation between Native Arteriogenesis and Therapeutic Synangiosis in Intracranial Arterial Steno-Occlusive Disease. AJNR Am J Neuroradiol. 2016 Jun;37(6):1086-91. doi: 10.3174/ajnr.A4675. Epub 2016 Jan 21.
PubMed 26797139Bilgin-Freiert A, Dusick JR, Stein NR, Etchepare M, Vespa P, Gonzalez NR. Muscle microdialysis to confirm sublethal ischemia in the induction of remote ischemic preconditioning. Transl Stroke Res. 2012 Jun;3(2):266-72. doi: 10.1007/s12975-012-0153-1. Epub 2012 Apr 10.
PubMed 24323782Dusick J, Hamilton R, Bilgin-Freiert A, Vespa P, Hu X, Asgari S, Gonzalez NR. Immediate Cerebrovascular and Brain Metabolic Effects of Remote Ischemic Preconditioning. Stroke; a journal of cerebral circulation. 2012; 43:A2698.
Gonzalez, N. R., Liou, R. J., Rao, N., Hinman, J. D., Restrepo, L., Ali, L., … Saver, J. (2016). Abstract TP119: Angiogenic Factor Profiling in Medical Treatment of Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATP119-ATP119.
Gonzalez, N. R., Ooi, Y., Laiwalla, A., Restrepo, L., Ali, L., Liou, R., … Saver, J. (2016). Abstract TMP15: Circulating Antiangiogenic Profile Predicts Lower Degrees of Neovascularization After Indirect Revascularization With Encephaloduroarteriosynangiosis (EDAS) in Patients With Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATMP15-ATMP15.
Gonzalez, N. R., Connolly, M. J., Ooi, Y. C., Dusick, J., Bounni, F., Liebeskind, D. S., … Iruela-Arispe, L. (2015). Abstract 135: Angiogenic Factors and Response to Intensive Medical Management in Atherosclerotic Intracranial Arterial Stenosis. Stroke, 46(Suppl 1), A135-A135.
Gonzalez, N. R., & Iruela-Arispe, L. (2014). Abstract T P90: Characterization of Inflammatory Cells after EDAS Surgery in Patients with Intracranial Arterial Stenosis. Stroke, 45(Suppl 1), ATP90-ATP90.
Gonzalez, N. R., Liou, R., Ooi, Y., Hinman, J. D., Rao, N., Toscano, J., … Saver, J. (2016). Abstract WP138: Effects of Intensive Medical Management (IMM) and Encephaloduroarteriosynangiosis (EDAS) On VEGFA165a/b Ratios in Patients With Intracranial Atherosclerosis (ICASi. Stroke, 47(Suppl 1), AWP138-AWP138.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
- ClinicalTrials.gov ID
- NCT02910180
- Acronym / sponsor ID
- Pro00045392
- Conditions
- Cerebrovascular Diseases, Ischemic Stroke, Repository
- Keywords
- Tissue Repository, Cerebrovascular Diseases, Stroke, Aneurysm, Arteriovenous malformation, Fistula, Intracranial Stenosis, Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Sep 2016 (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.
This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This is a prospective observational study which will use samples from such patients to create this library which can be used to explore these questions in the future.
Detailed description
Genetic and metabolic profiling has become an important means to evaluate various pathologies, their effects on patients, and their treatments. In regards to cerebrovascular disease and stroke, there are a number of hypotheses which have been proposed. The levels and types of various angiogenic factors in the blood and tissues have been proposed to be predictive of patient outcome after ischemic stroke and treatment for stroke. Likewise, genetic factors may predict outcome or response to various types of treatments.
The role of biological samples in furthering our understandings about cerebrovascular disease and treatment are well documented. Muscle microdialysis samples have confirmed the presence of sublethal ischemia during the induction of remote ischemic preconditioning. The effects of remote ischemic preconditioning on the coagulation profile, DNA methylation, and cell cycle gene expression of patients with aneurysmal subarachnoid hemorrhage have also been elucidated. Blood samples collected in patients with intracranial arterial stenosis have produced many insights. Inflammatory cell profiles in patient who receive encephaloduroarteriosynangiosis (EDAS) surgery have been characterized. Angiogenic factor measurements have been shown to predict the degree of neovascularization in patients post-EDAS. In patients with intracranial atherosclerosis, angiogenic factor profiles were found to strongly correlate with failure of medical management and poor outcomes.
It is clear that genetic and metabolic profiling are effective tools in evaluating the effects of cerebrovascular disease and their treatments. This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. For every patient enrolled in the study, relevant patient information such as age, gender, diagnosis, medical history, family history, procedures/treatments received, radiological reports, and patient outcomes are recorded. This information is updated upon every follow-up during the study. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples.
Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This repository serves as the groundwork to explore these questions in the future.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repository Group | – | –The Repository Group consists of patients which have donated tissue to the repository. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with cerebrovascular disease. This includes both non-surgical patients (such medically managed ischemic stroke, aneurysms, moyamoya disease, arteriovenous malformation, hemorrhagic stroke, etc.) and surgically treated patients (patients with aneurysm coiling or clipping, arteriovenous malformation resection, direct or indirect revascularization procedures for ischemia, etc.).
Key inclusion criteria (3 listed)
- All patients diagnosed with cerebral vascular disease, regardless of gender, age, ethnicity/race, stage of disease or treatment, are eligible.
- Expected availability of clinical follow up data
- Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines.
Key exclusion criteria (1 listed)
- Pregnant women are excluded from the study.
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
Change in modified Rankin Scale (mRS) score
Time frame: Baseline, 1 Month, 3 Months, and 6 Months
Change in NIH Stroke Scale score
Time frame: Baseline, 1 Month, 3 Months, and 6 Months
Change in Barthel Index
Time frame: Baseline, 1 Month, 3 Months, and 6 Months
Change in Montreal Cognitive Assessment test score
Time frame: Baseline, 1 Month, 3 Months, and 6 Months
2 secondary outcomes
Change in Angiographic Neovascularization
Time frame: Baseline and 6 Months
Change in Angiogenic Factor Measurements
Time frame: Baseline, 1 Month, 3 Months, 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 23867300Mayor F, Bilgin-Freiert A, Connolly M, Katsnelson M, Dusick JR, Vespa P, Koch S, Gonzalez NR. Effects of remote ischemic preconditioning on the coagulation profile of patients with aneurysmal subarachnoid hemorrhage: a case-control study. Neurosurgery. 2013 Nov;73(5):808-15; discussion 815. doi: 10.1227/NEU.0000000000000098.
- Background: PubMed 26251247Nikkola E, Laiwalla A, Ko A, Alvarez M, Connolly M, Ooi YC, Hsu W, Bui A, Pajukanta P, Gonzalez NR. Remote Ischemic Conditioning Alters Methylation and Expression of Cell Cycle Genes in Aneurysmal Subarachnoid Hemorrhage. Stroke. 2015 Sep;46(9):2445-51. doi: 10.1161/STROKEAHA.115.009618. Epub 2015 Aug 6.
- Background: PubMed 26797139Ooi YC, Laiwalla AN, Liou R, Gonzalez NR. Angiographic Structural Differentiation between Native Arteriogenesis and Therapeutic Synangiosis in Intracranial Arterial Steno-Occlusive Disease. AJNR Am J Neuroradiol. 2016 Jun;37(6):1086-91. doi: 10.3174/ajnr.A4675. Epub 2016 Jan 21.
- Background: PubMed 24323782Bilgin-Freiert A, Dusick JR, Stein NR, Etchepare M, Vespa P, Gonzalez NR. Muscle microdialysis to confirm sublethal ischemia in the induction of remote ischemic preconditioning. Transl Stroke Res. 2012 Jun;3(2):266-72. doi: 10.1007/s12975-012-0153-1. Epub 2012 Apr 10.
- BackgroundDusick J, Hamilton R, Bilgin-Freiert A, Vespa P, Hu X, Asgari S, Gonzalez NR. Immediate Cerebrovascular and Brain Metabolic Effects of Remote Ischemic Preconditioning. Stroke; a journal of cerebral circulation. 2012; 43:A2698.
- BackgroundGonzalez, N. R., Liou, R. J., Rao, N., Hinman, J. D., Restrepo, L., Ali, L., … Saver, J. (2016). Abstract TP119: Angiogenic Factor Profiling in Medical Treatment of Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATP119-ATP119.
- BackgroundGonzalez, N. R., Ooi, Y., Laiwalla, A., Restrepo, L., Ali, L., Liou, R., … Saver, J. (2016). Abstract TMP15: Circulating Antiangiogenic Profile Predicts Lower Degrees of Neovascularization After Indirect Revascularization With Encephaloduroarteriosynangiosis (EDAS) in Patients With Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATMP15-ATMP15.
- BackgroundGonzalez, N. R., Connolly, M. J., Ooi, Y. C., Dusick, J., Bounni, F., Liebeskind, D. S., … Iruela-Arispe, L. (2015). Abstract 135: Angiogenic Factors and Response to Intensive Medical Management in Atherosclerotic Intracranial Arterial Stenosis. Stroke, 46(Suppl 1), A135-A135.
- BackgroundGonzalez, N. R., & Iruela-Arispe, L. (2014). Abstract T P90: Characterization of Inflammatory Cells after EDAS Surgery in Patients with Intracranial Arterial Stenosis. Stroke, 45(Suppl 1), ATP90-ATP90.
- BackgroundGonzalez, N. R., Liou, R., Ooi, Y., Hinman, J. D., Rao, N., Toscano, J., … Saver, J. (2016). Abstract WP138: Effects of Intensive Medical Management (IMM) and Encephaloduroarteriosynangiosis (EDAS) On VEGFA165a/b Ratios in Patients With Intracranial Atherosclerosis (ICASi. Stroke, 47(Suppl 1), AWP138-AWP138.
- Individual participant dataSharing planned: Yes
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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.
Nestor R Gonzalez, MD, MSCR principal investigator
Cedars-Sinai 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 Cerebrovascular Diseases and Ischemic Stroke, run by Cedars-Sinai Medical Center 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Feb 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nestor R Gonzalez, MD, MSCR ((310) 423-0783, Nestor.Gonzalez@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Rankin Scale (mRS) score (time frame: Baseline, 1 Month, 3 Months, and 6 Months). The study lists 4 primary outcomes in all. 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 NCT02910180, which also lists 10 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 8 Feb 2023.