Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

Predictive Values of Serum Adiponectin Levels in Aneurysmal Subarachnoid Hemorrhage.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02814162
• Other study ID #: TDSJWKSAH
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2016
• Last updated: March 29, 2017
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Tang-Du Hospital
• Contact: Yan Qu, M.D Ph.D
• Phone: 86-18629074363
• Email: yanqu0123[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Locations

Country	Name	City	State
China	Tandu Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Epub 2005 Aug 18. — View 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. Epub 2007 Jan 9. — View 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. Epub 2007 Jan 23. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cerebral vasospasm and delayed cerebral ischemia	Proved by clinical and radiologic evidence	30 days post SAH
Secondary	Death		30 days post SAH
Secondary	National institutes of health stroke scale (NIHSS) score	Assessing by senior neurosurgeons	On discharge or 14 days (whichever occurs first) and 30 days post SAH
Secondary	Modified Rankin scale (mRS)	By phone call following-up	30 days and 90days post SAH