A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- biomechanical properties of the carotid arteries
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
biomechanical properties of the carotid arteries
时间窗: 1-6 months
次要结局
- respiratory parameters recorded during sleep(1-6 months)
- blood pressure (BP) levels and the vascular parameters(1-6 months)
- aortic stiffness and brachial endothelial function(1-6 months)