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Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome (AVC/SCA)

2009年8月21日 更新者:University Hospital, Grenoble

A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.

The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.

研究概览

详细说明

A comparative study of structural and functional arterial properties after an ischaemic stroke or an acute coronary syndrome

Objectives:

Primary:

  • To determine whether there is a difference in the biomechanical properties of the carotid arteries, assessed by studying their stiffness, after an acute vascular event, depending on whether the event is an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).

Secondary:

  • To determine whether there is a difference in aortic stiffness and brachial endothelial function after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
  • To compare the blood pressure (BP) levels and the vascular parameters of the two patient groups (the ischaemic stroke group and the ACS group).
  • To determine whether there is a difference between the respiratory parameters recorded during sleep after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.

研究类型

观察性的

注册 (预期的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Grenoble、法国
        • 招聘中
        • University Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who presented an acute vascular event :an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).

描述

Inclusion Criteria:

  • Male and female patients
  • Between 40 and 70 years of age
  • Who have given their written consent
  • Who have presented the following between 5 and 30 days prior to inclusion:
  • either an ischaemic stroke (full stroke or TIA) that has been stabilised from a neurological point of view, with no haemorrhage but with direct signs of ischaemia on the cerebral imaging (computed tomography or MRI), diagnosed during patient questioning and/or the clinical examination;
  • or an ACS that has been stabilised from a cardiological point of view, with troponin elevation in at least 2 samples and/or ECG changes that indicate acute myocardial ischaemia, diagnosed during patient questioning.
  • Who are affiliated to the French social security system

Exclusion Criteria:

  • For patients included in the ACS group

    • Stroke less than 6 months ago
    • Coronary bypass between the start of their hospitalisation for ACS and inclusion
  • For patients included in the stroke group

    • Emboligenic heart disease
    • ACS less than 6 months ago
  • For all patients

    • Atrial fibrillation or flutter, or frequent extrasystole (more than 10/minute) upon inclusion
    • History of surgery or carotid stenting
    • Very reduced mobility meaning that they cannot remain standing without assistance or without using a walking stick

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
1
patients who presented an ischaemic stroke(full stroke or TIA)
2
patients who present an acute coronary syndrome (ACS).

研究衡量的是什么?

主要结果指标

结果测量
大体时间
biomechanical properties of the carotid arteries
大体时间:1-6 months
1-6 months

次要结果测量

结果测量
大体时间
aortic stiffness and brachial endothelial function
大体时间:1-6 months
1-6 months
blood pressure (BP) levels and the vascular parameters
大体时间:1-6 months
1-6 months
respiratory parameters recorded during sleep
大体时间:1-6 months
1-6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:BAGUET Jean Philippe, Professor、University Hospital, Grenoble

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年11月1日

初级完成 (预期的)

2009年10月1日

研究完成 (预期的)

2009年10月1日

研究注册日期

首次提交

2009年3月23日

首先提交符合 QC 标准的

2009年6月23日

首次发布 (估计)

2009年6月24日

研究记录更新

最后更新发布 (估计)

2009年8月25日

上次提交的符合 QC 标准的更新

2009年8月21日

最后验证

2009年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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