Subarachnoid Hemorrhage, AneurysmalNCT02814162
Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Tang-Du Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Aug 2017
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with aneurysmal subarachnoid hemorrhage who are hospitalized within 24 hours from onset.
Who may be able to join
- Age>18yrs and age<90yrs
- It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
- Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- SAH grade is assessed by Hunt \& Hess classification
- Informed consented
Who cannot join
- Traumatic subarachnoid hemorrhage
- Patients with cerebral herniation or highly possible to occur within 2 days from SAH
- Length of hospital stay is expected to be less than 5 days
- Duration from onset to admission is more than 48 hours
- Disturbance of communication or poor compliance to blood collection, imaging examination and follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
Yan Qu, M.D Ph.D, 86-18629074363, yanqu0123@icloud.com
Min Li, M.D Ph.D, 86-15319053136, neursylm@163.com
About this study
The purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients.
Read the detailed description
Adiponectin (APN) is an abundant protein hormone derived from adipose tissue. It has been suggested to exert anti-inflammatory, antiatherogenic, and vascular protective. Subarachnoid hemorrhage (SAH) comprises about 5% of all strokes with high mortality and permanent disability rates. Although many patients survive from the initial hemorrhage or rebleeding, they suffered from long-term delayed neurological deficits (DNDs), including stroke, delayed cerebral ischemia, cognitive and neuropsychological abnormalities that seriously impact overall function and quality of life. Ruptured cerebral aneurysms are the most common cause of SAH. There is growing evidence supporting APN act as a predictive factor for SAH. The observational study will focus on the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage (aSAH).
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Subarachnoid Hemorrhage, Aneurysmal, Predictive, Adiponectin
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cerebral vasospasm and delayed cerebral ischemia
Proved by clinical and radiologic evidence
Measured: 30 days post SAH
Secondary outcomes (3)
Death
Measured: 30 days post SAH
National institutes of health stroke scale (NIHSS) score
Assessing by senior neurosurgeons
Measured: On discharge or 14 days (whichever occurs first) and 30 days post SAH
Modified Rankin scale (mRS)
By phone call following-up
Measured: 30 days and 90days post SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814162
- Sponsor's protocol ID
- TDSJWKSAH
- Status last verified
- Mar 2017
- First submitted
- 2 May 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thundyil J, Tang SC, Okun E, Shah K, Karamyan VT, Li YI, Woodruff TM, Taylor SM, Jo DG, Mattson MP, Arumugam TV. Evidence that adiponectin receptor 1 activation exacerbates ischemic neuronal death. Exp Transl Stroke Med. 2010 Aug 11;2(1):15. doi: 10.1186/2040-7378-2-15.
PubMed 20701790Osuka K, Watanabe Y, Yasuda M, Takayasu M. Adiponectin activates endothelial nitric oxide synthase through AMPK signaling after subarachnoid hemorrhage. Neurosci Lett. 2012 Apr 11;514(1):2-5. doi: 10.1016/j.neulet.2011.12.041. Epub 2012 Jan 3.
PubMed 22230897Psilopanagioti A, Papadaki H, Kranioti EF, Alexandrides TK, Varakis JN. Expression of adiponectin and adiponectin receptors in human pituitary gland and brain. Neuroendocrinology. 2009;89(1):38-47. doi: 10.1159/000151396. Epub 2008 Aug 13.
PubMed 18698133Kos K, Harte AL, da Silva NF, Tonchev A, Chaldakov G, James S, Snead DR, Hoggart B, O'Hare JP, McTernan PG, Kumar S. Adiponectin and resistin in human cerebrospinal fluid and expression of adiponectin receptors in the human hypothalamus. J Clin Endocrinol Metab. 2007 Mar;92(3):1129-36. doi: 10.1210/jc.2006-1841. Epub 2007 Jan 9.
PubMed 17213280Kusminski CM, McTernan PG, Schraw T, Kos K, O'Hare JP, Ahima R, Kumar S, Scherer PE. Adiponectin complexes in human cerebrospinal fluid: distinct complex distribution from serum. Diabetologia. 2007 Mar;50(3):634-42. doi: 10.1007/s00125-006-0577-9. Epub 2007 Jan 23.
PubMed 17242917Efstathiou SP, Tsioulos DI, Tsiakou AG, Gratsias YE, Pefanis AV, Mountokalakis TD. Plasma adiponectin levels and five-year survival after first-ever ischemic stroke. Stroke. 2005 Sep;36(9):1915-9. doi: 10.1161/01.STR.0000177874.29849.f0. Epub 2005 Aug 18.
PubMed 16109902Takeuchi S, Wada K, Otani N, Osada H, Nagatani K, Mori K. Temporal profile of plasma adiponectin level and delayed cerebral ischemia in patients with subarachnoid hemorrhage. J Clin Neurosci. 2014 Jun;21(6):1007-10. doi: 10.1016/j.jocn.2013.10.020. Epub 2013 Dec 22.
PubMed 24594449
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.
- ClinicalTrials.gov ID
- NCT02814162
- Acronym / sponsor ID
- TDSJWKSAH
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Subarachnoid Hemorrhage, Aneurysmal, Predictive, Adiponectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 27 Jun 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.
The purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients.
Detailed description
Adiponectin (APN) is an abundant protein hormone derived from adipose tissue. It has been suggested to exert anti-inflammatory, antiatherogenic, and vascular protective. Subarachnoid hemorrhage (SAH) comprises about 5% of all strokes with high mortality and permanent disability rates. Although many patients survive from the initial hemorrhage or rebleeding, they suffered from long-term delayed neurological deficits (DNDs), including stroke, delayed cerebral ischemia, cognitive and neuropsychological abnormalities that seriously impact overall function and quality of life. Ruptured cerebral aneurysms are the most common cause of SAH. There is growing evidence supporting APN act as a predictive factor for SAH. The observational study will focus on the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage (aSAH).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aneurysmal subarachnoid hemorrhage who are hospitalized within 24 hours from onset.
Key inclusion criteria (5 listed)
- Age>18yrs and age<90yrs
- It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
- Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- SAH grade is assessed by Hunt \& Hess classification
- Informed consented
Key exclusion criteria (5 listed)
- Traumatic subarachnoid hemorrhage
- Patients with cerebral herniation or highly possible to occur within 2 days from SAH
- Length of hospital stay is expected to be less than 5 days
- Duration from onset to admission is more than 48 hours
- Disturbance of communication or poor compliance to blood collection, imaging examination and follow-up
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
Incidence of cerebral vasospasm and delayed cerebral ischemia
Time frame: 30 days post SAH
Proved by clinical and radiologic evidence
3 secondary outcomes
Death
Time frame: 30 days post SAH
National institutes of health stroke scale (NIHSS) score
Time frame: On discharge or 14 days (whichever occurs first) and 30 days post SAH
Modified Rankin scale (mRS)
Time frame: 30 days and 90days post SAH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Background: PubMed 20701790Thundyil J, Tang SC, Okun E, Shah K, Karamyan VT, Li YI, Woodruff TM, Taylor SM, Jo DG, Mattson MP, Arumugam TV. Evidence that adiponectin receptor 1 activation exacerbates ischemic neuronal death. Exp Transl Stroke Med. 2010 Aug 11;2(1):15. doi: 10.1186/2040-7378-2-15.
- Background: PubMed 22230897Osuka K, Watanabe Y, Yasuda M, Takayasu M. Adiponectin activates endothelial nitric oxide synthase through AMPK signaling after subarachnoid hemorrhage. Neurosci Lett. 2012 Apr 11;514(1):2-5. doi: 10.1016/j.neulet.2011.12.041. Epub 2012 Jan 3.
- Background: PubMed 18698133Psilopanagioti A, Papadaki H, Kranioti EF, Alexandrides TK, Varakis JN. Expression of adiponectin and adiponectin receptors in human pituitary gland and brain. Neuroendocrinology. 2009;89(1):38-47. doi: 10.1159/000151396. Epub 2008 Aug 13.
- Background: PubMed 17213280Kos K, Harte AL, da Silva NF, Tonchev A, Chaldakov G, James S, Snead DR, Hoggart B, O'Hare JP, McTernan PG, Kumar S. Adiponectin and resistin in human cerebrospinal fluid and expression of adiponectin receptors in the human hypothalamus. J Clin Endocrinol Metab. 2007 Mar;92(3):1129-36. doi: 10.1210/jc.2006-1841. Epub 2007 Jan 9.
- Background: PubMed 17242917Kusminski CM, McTernan PG, Schraw T, Kos K, O'Hare JP, Ahima R, Kumar S, Scherer PE. Adiponectin complexes in human cerebrospinal fluid: distinct complex distribution from serum. Diabetologia. 2007 Mar;50(3):634-42. doi: 10.1007/s00125-006-0577-9. Epub 2007 Jan 23.
- Background: PubMed 16109902Efstathiou SP, Tsioulos DI, Tsiakou AG, Gratsias YE, Pefanis AV, Mountokalakis TD. Plasma adiponectin levels and five-year survival after first-ever ischemic stroke. Stroke. 2005 Sep;36(9):1915-9. doi: 10.1161/01.STR.0000177874.29849.f0. Epub 2005 Aug 18.
- Background: PubMed 24594449Takeuchi S, Wada K, Otani N, Osada H, Nagatani K, Mori K. Temporal profile of plasma adiponectin level and delayed cerebral ischemia in patients with subarachnoid hemorrhage. J Clin Neurosci. 2014 Jun;21(6):1007-10. doi: 10.1016/j.jocn.2013.10.020. Epub 2013 Dec 22.
- Individual participant dataSharing planned: No
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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.
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 Subarachnoid Hemorrhage, Aneurysmal, run by Tang-Du Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 31 Mar 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Qu, M.D Ph.D (86-18629074363, yanqu0123@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cerebral vasospasm and delayed cerebral ischemia (time frame: 30 days post SAH). 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 NCT02814162, which also lists 7 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 31 Mar 2017.