Clinical trial NCT02814162: Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.
Official title: Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: Subarachnoid Hemorrhage, Aneurysmal
Predictive
Adiponectin
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aneurysmal subarachnoid hemorrhage who are hospitalized within 24 hours from onset.

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of cerebral vasospasm and delayed cerebral ischemia
timeFrame: 30 days post SAH
Secondary outcomes:
measure: Death
timeFrame: 30 days post SAH
measure: National institutes of health stroke scale (NIHSS) score
timeFrame: On discharge or 14 days (whichever occurs first) and 30 days post SAH
measure: Modified Rankin scale (mRS)
timeFrame: 30 days and 90days post SAH
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tandu Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
citation: 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.
citation: Osuka 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.
citation: Psilopanagioti 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.
citation: Kos 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.
citation: Kusminski 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.
citation: Efstathiou 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.
citation: Takeuchi 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.