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研究方案:巴基斯坦人群中的无症状颅内动脉粥样硬化疾病

Study protocol: asymptomatic intracranial atherosclerotic disease in pakistanis.

作者信息

Kamal Ayeesha Kamran, Majeed Farzin, Pasha Omrana, Islam Muhammad, Azam Iqbal, Ilyas Muhammad Saleem, Hussain Munawar, Masood Kamran, Ahmed Bilal, Nazir Sumaira, Sajjad Zafar, Kasner Scott E

机构信息

Associate Professor Neurology, Stroke Service, The International Cerebrovascular Translational Clinical Research Training Program (Fogarty International Center, National Institutes of Health) and Aga Khan University, Karachi, Pakistan ; Joint First Authors ; Corresponding Author.

Fogarty Cerebrovascular Research Fellow, The International Cerebrovascular Translational Clinical Research Training Program (Fogarty International Center, National Institutes of Health) and Aga Khan University, Karachi, Pakistan ; Joint First Authors.

出版信息

J Vasc Interv Neurol. 2015 Feb;8(1):27-35.

Abstract

BACKGROUND

Intracranial atherosclerotic disease (ICAD) is the most frequent subtype of ischemic stroke globally. It is important to describe the determinants of early ICAD as a strategy to prevent strokes from clinically evident and progressive ICAD. Our objective is to report the determinants of asymptomatic ICAD by linking the presence or absence of ICAD on magnetic resonance angiogram (MRA) with detailed risk assessment in asymptomatic adults.

METHODS

This is an observational cross-sectional analytical study. We plan to recruit 200 adult participants from the radiology departments of two tertiary care centers of Karachi, Pakistan. The participants will first be screened for the absence of stroke symptoms via the Questionnaire for Verifying Stroke Free Status (QVSFS). QVSFS negative will be participants will be eligible. After written informed consent, participants will undergo detailed medical, sociodemographic, lifestyle, and anthropometric evaluation by a detailed interview. They will, in addition, undergo MRA to study the presence, degree, and distribution of asymptomatic ICAD. All MRA scans will be reviewed centrally by vascular neurologists blinded to clinical information. These images would be reviewed on DICOM Viewer 3.0 used for calculating the degree of stenosis using Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study defined criteria employing electronic calipers. A sample size of 200 will achieve 80% power for detecting a minimum difference of 20% in the prevalence of exposure factors (medical and lifestyle) between asymptomatic ICAD positive and ICAD negative persons. This study will generate regional data on risks for ICAD development and prevention in a high-risk susceptible population. Study ID: NCT02072876.

摘要

背景

颅内动脉粥样硬化疾病(ICAD)是全球缺血性卒中最常见的亚型。描述早期ICAD的决定因素作为预防临床明显且进展性ICAD所致卒中的一种策略很重要。我们的目的是通过将无症状成年人磁共振血管造影(MRA)上ICAD的有无与详细的风险评估相联系,报告无症状ICAD的决定因素。

方法

这是一项观察性横断面分析研究。我们计划从巴基斯坦卡拉奇两家三级医疗中心的放射科招募200名成年参与者。首先通过无卒中状态验证问卷(QVSFS)对参与者进行无卒中症状筛查。QVSFS结果为阴性的参与者将符合条件。在获得书面知情同意后,参与者将通过详细访谈接受详细的医学、社会人口统计学、生活方式和人体测量学评估。此外,他们将接受MRA检查,以研究无症状ICAD的存在、程度和分布情况。所有MRA扫描图像将由对临床信息不知情的血管神经科医生进行集中审查。这些图像将在DICOM Viewer 3.0上进行审查,使用华法林 - 阿司匹林有症状颅内疾病(WASID)研究定义的标准,采用电子卡尺计算狭窄程度。样本量为200将有80%的把握度检测出无症状ICAD阳性和ICAD阴性者之间暴露因素(医学和生活方式)患病率至少20%的差异。本研究将在高危易感人群中生成关于ICAD发生和预防风险的区域数据。研究编号:NCT02072876。

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