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临床试验/NCT04613427
NCT04613427已完成不适用

Predictors of Rupture Risk of Intracranial Aneurysms - Impact of Lipid Metabolism and Mitochondrial Function

University of Bergen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Anthropometric risk factors of ruptured versus unruptured intracranial aneurysms

研究概览

简要总结

Patients admitted to Haukeland University Hospital with either UIA or aSAH underwent a measurement of bioelectrical impedance and body mass composition using InBody 10. Lipids and lipoproteins were collected from plasma. 60 patients in total were included in the study.

详细描述

Subarachnoid hemorrhage (SAH) is a condition mainly caused by the rupture of intracranial aneurysms. The estimated prevalence of intracranial aneurysms in the general population is 1-2%, with an annual incidence of aneurysm rupture causing subarachnoid hemorrhage estimated around 1% in Norway. The mortality rates for aneurysmal subarachnoid hemorrhage (aSAH) are as high as 35%, and for the survivors the condition represents a significant morbidity with long-term cognitive impairment and other challenges. With a mean age of 51-55 years at presentation, the burden, both for the patients themselves and on health care resources, is substantial.

Thus, the risk assessment and management of patients with unruptured intracranial aneurysms (UIA) represents a substantial challenge. The number of patients with incidentally discovered cerebral aneurysms is rapidly growing with the increasing use of non-invasive intracranial magnetic resonance imaging (MRI). Therapy options are endovascular coiling, neurosurgical clipping, or observation. To decide whether to perform a potentially harmful prophylactic procedure or not, better tools to predict the risk of rupture in the given individual are required.

Some risk factors, both for the development of an intracranial aneurysm and for the rupture leading to hemorrhage are identified, such as hypertension, age and smoking. Recent research has shown that obesity and hypercholesterolemia is surprisingly associated with an apparent lower risk of aSAH. However, underlying body composition and dyslipidemic patterns has not yet been explored. Increased knowledge of predictors for aneurysm rupture is required, both to improve the patient care and the decision-making concerning the neurosurgical prevention of aSAH.

In the RAPID project, the investigators aim to identify potential new risk factors for the rupture of intracranial aneurysms by comparing the lipid and lipoprotein profile and the body mass composition in patients with UIA and aSAH.

Direct-segmental multisegmental bioimpedance analysis (DSM-BIA) is a valid tool for the assessment of total body and segmental composition and has shown excellent agreements when compared with dual energy X-ray absorptiometry (DEXA). Body composition will be analysed within day 2 after intervention or surgery using a DSM-BIA scanner (InBody S10, BioSpace Ltd, Seoul, South Korea).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted electively for treatment of unruptured intracranial aneurysm
  • Admitted acutely for aneurysmal subarachnoid hemorrhage
  • Informed consent form signed by patient or close relative

排除标准

  • Pacemaker
  • Subarachnoid hemorrhage without identified aneurysmal rupture
  • Unruptured aneurysm with previous SAH/intracranial hemorrhage

结局指标

主要结局

Anthropometric risk factors of ruptured versus unruptured intracranial aneurysms

时间窗: The anthropometric data will be collected within 96 hours after admittance, as well as information on the predictors and risk factors from the patient journal.

The case group with SAH patients will be compared to the control group with UIA patients. The anthropometric variables is measured by InBody S10 and includes BMI, waist circumference, visceral fat area, body fat mass, body fat percentage, fat free mass, and skeletal muscle mass. The waist/height ratio will be calculated. The data will be analyzed by generalized linear modeling (logistic regression), and the models will be controlled for prognostic factors, including sex, age, hypertension, smoking, alcoholism, statin use, family history of SAH, aneurysm size, diabetes, and cardiovascular disease.

次要结局

  • Lipid ratios as risk factors of ruptured versus unruptured intracranial aneurysms(The calculations will be performed prior to statistical analyses within 3 years after study completion (June 2022).)
  • Lipoprotein subclass risk factors of ruptured versus unruptured intracranial aneurysms.(Blood samples collection within 96 hours after admittance.)
  • Standard lipid risk factors of ruptured versus unruptured intracranial aneurysms(Blood samples collection within 96 hours after admittance. Calculations will be performed within 3 years after study completion (June 2022).)
  • Apolipoprotein A1/B ratio as a risk factor of ruptured versus unruptured intracranial aneurysms(Calculations will be performed within 3 years after study completion (June 2022).)
  • Apolipoprotein risk factors of ruptured versus unruptured intracranial aneurysms(Blood samples collection within 96 hours after admittance.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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