Clinical trial NCT01038193: Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage
Official title: Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Keywords: Cognition, subarachnoid hemorrhage.
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aneurysmal subarachnoid hemorrhage patients

Brief summary: This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Detailed description: The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.

Eligibility criteria: Inclusion criteria

1. Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology
2. Admission within 96 hours of ictus
3. Aged between 21 and 75 years
4. A speaker of Chinese (Mandarin or Cantonese)
5. Informed consent from patients or their legally acceptable representatives

Exclusion criteria

1. History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm
2. History of neurosurgical operation prior to ictus

Primary outcomes:
measure: Cognitive dysfunction
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Neurological Outcome
timeFrame: 3 and 12 months
measure: Generic Quality of Life
timeFrame: 3 and 12 months
measure: Activity of Daily Living
timeFrame: 3 and 12 months
measure: Disease-specific Quality of Life
timeFrame: 3 and 12 months
measure: Functional Outcome
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Division of Neurosurgery, CUHK
name: George KC Wong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong GK, Lam SW, Wong A, Ngai K, Mok V, Poon WS. Early Cognitive Domain Deficits in Patients with Aneurysmal Subarachnoid Hemorrhage Correlate with Functional Status. Acta Neurochir Suppl. 2016;122:129-32. doi: 10.1007/978-3-319-22533-3_26.
citation: Wong GK, Wong A, Zee BC, Poon WS, Chan MT, Gin T, Siu DY, Mok VC. Cognitive outcome in acute simvastatin treatment for aneurysmal subarachnoid hemorrhage: A propensity matched analysis. J Neurol Sci. 2015 Nov 15;358(1-2):58-61. doi: 10.1016/j.jns.2015.08.013. Epub 2015 Aug 12.
citation: Chu AC, Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Cognitive impairment in aneurysmal subarachnoid hemorrhage patients with delayed cerebral infarction: prevalence and pattern. Acta Neurochir Suppl. 2015;120:303-6. doi: 10.1007/978-3-319-04981-6_51.
citation: Wong GK, Lam SW, Wong A, Lai M, Siu D, Poon WS, Mok V. MoCA-assessed cognitive function and excellent outcome after aneurysmal subarachnoid hemorrhage at 1 year. Eur J Neurol. 2014 May;21(5):725-30. doi: 10.1111/ene.12363. Epub 2014 Jan 28.
citation: Wong GK, Lam SW, Wong A, Mok V, Siu D, Ngai K, Poon WS. Early MoCA-assessed cognitive impairment after aneurysmal subarachnoid hemorrhage and relationship to 1-year functional outcome. Transl Stroke Res. 2014 Apr;5(2):286-91. doi: 10.1007/s12975-013-0284-z. Epub 2013 Sep 7.
citation: Wong GK, Lam SW, Ngai K, Wong A, Poon WS, Mok V. Development of a short form of Stroke-Specific Quality of Life Scale for patients after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2013 Dec 15;335(1-2):204-9. doi: 10.1016/j.jns.2013.09.033. Epub 2013 Oct 2.
citation: Wong GK, Lam SW, Ngai K, Wong A, Siu D, Poon WS, Mok V; Cognitive Dysfunction after Aneurysmal Subarachnoid Hemorrhage Investigators. Cognitive domain deficits in patients with aneurysmal subarachnoid haemorrhage at 1 year. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1054-8. doi: 10.1136/jnnp-2012-304517. Epub 2013 Apr 20.
citation: Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Comparison of montreal cognitive assessment and mini-mental state examination in evaluating cognitive domain deficit following aneurysmal subarachnoid haemorrhage. PLoS One. 2013;8(4):e59946. doi: 10.1371/journal.pone.0059946. Epub 2013 Apr 3.
citation: Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.