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临床试验/NCT02072876
NCT02072876已完成不适用

Asymptomatic Intracranial Atherosclerotic Disease: Prevalence, Clinical and Lifestyle Determinants in Urban Pakistan

Aga Khan University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Distribution and Degree of Asymptomatic Intracranial Stenosis

研究概览

简要总结

The incidence of stroke has increased by 100% in the last four decades in developing countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited therapeutic options. Therefore, it is imperative to delineate the determinants of asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20% difference in the proportion of clinical, life-style (dietary, physical activity, obesity, smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than those with no ICAD.

详细描述

Stroke is a major emerging cause of adult disability and the 3rd leading non-communicable cause of mortality in the world . With half of the world's population living in Asia, stroke epidemiology and its risk factor determination is important globally. The changes in population demographics and continuing industrialization in Asia have also led to a change in the epidemiology of stroke sub-types . Among the ischemic stroke sub-types, Intracranial Atherosclerotic disease is now emerging as the most prevalent vascular cause of stroke with high prevalence in Asian, African and Hispanic individuals .

Patients with ICAD are at a significant risk for recurrent stroke, with a risk as high as 25% in the first two years . Rate of recurrent stroke also varies by the location of the affected artery. Risk factor management is extremely important for the primary and secondary prevention of stroke in Asia as it is in Western countries. With the changing demographics and relatively fewer cost effective treatment modalities available, particularly for resource poor countries like Pakistan, it is imperative to delineate the clinical as well as lifestyle risk factors at an earlier asymptomatic stage to prevent future life-threatening consequences.

Therefore the primary objective of this study is to determine the clinical, lifestyle, dietary and psycho-social determinants of asymptomatic Intracranial Atherosclerotic disease (ICAD) and its other associated Brain MRI findings namely brain volume reduction, silent brain infarcts, and peri-ventricular hyper intensities in clinically normal adults with ICAD on MRI Brain.

研究设计

研究类型
Observational

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

  • Adult Pakistani men and women ≥ 18years getting MRI brain for any indication other than stroke.
  • Permanent residents of Pakistan for at least 1 year.
  • No prior history of stroke which was confirmed by screening with Questionnaire for verifying stroke free status (QVSFS).
  • Able to give written informed consent.

排除标准

  • QVSFS +ve.
  • Severe disability, life expectancy less than 6 months at enrollment.
  • Patients in whom MRI prolongation for 5 minutes can be harmful for the patient (Anesthesia, claustrophobia, sedation etc.).
  • Any clear contraindications to MRI, like pacemakers, metallic valves

结局指标

主要结局

Distribution and Degree of Asymptomatic Intracranial Stenosis

时间窗: MRA , Once , Over One Year

This was defined as any artery (Internal Carotid Artery ICA, Middle Cerebral Artery MCA,Anterior Cerebral Artery ACA,Posterior Cerebral Artery PCA, Basilar Artery BA, and Vertebral Artery VA) having \>25% stenosis on MRA. An internationally standardized ( WASID) equation was used to calculate the degree of stenosis. Percent stenosis= \[1- (Dstenosis/D normal)\*100\], where D Stenosis is the diameter of the artery at the site of the most severe stenosis, and D normal= diameter of the proximal normal artery.

次要结局

  • Associated Brain MRI Findings with Intracranial Stenosis(MRA Once , Over One Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ayeesha Kamran Kamal

Associate Professor Neurology,Director Stroke Fellowship Program

Aga Khan University

研究点 (2)

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