跳至主要内容
临床试验/NCT04555538
NCT04555538Unknown不适用

Atrial Cardiac Magnetic Resonance Imaging in Patients With Embolic Stroke of Unknown Source Without Documented Atrial Fibrillation

Guy's and St Thomas' NHS Foundation Trust3 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
92
试验地点
3
主要终点
AF Predictors

研究概览

简要总结

This research study will investigate a new method for identifying which patients should be offered blood thinners or therapies to reverse the underlying causes after stroke.

Atrial fibrillation(AF) is the primary risk factor for ischaemic stroke, increasing the risk by up to 5-fold. In AF, the upper heart chambers don't pump blood effectively into the lower chambers. When this happens, a blood clot can form, dislodge and leave the heart blocking an artery in the brain and cause a stroke. However, AF is often an intermittent condition and therefore difficult to diagnose. As such, there are a group of patients in whom no cause of their stroke can be identified.

In this study, we will recruit 92 patients from Guy's and St Thomas' Hospital, Princess Royal University Hospital and King's College London.

As part of routine clinical care, patients undergo insertion of an Implantable Loop Recorder (CE Marked device), a minimally invasive procedure that allows accurate beat-to-beat monitoring to identify patients who develop intermittent AF post-stroke. We will request access to the data collected from this device and perform atrial MRI imaging in these patients to compare the findings between patients that do and do not have AF. If we show that atrial MRI scans are significantly different between patients with and without AF, we will use this information to support a trial of starting appropriate therapies (e.g. blood thinners) in these patients on the basis of MRI findings. This approach would have the advantage of enabling therapies to be offered to the right patients earlier and prevent repeat, potentially disabling stroke.

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

  • Patients will be recruited within 3 months of an acute ischaemic stroke. It must also be feasible to perform a cardiac MRI on all patients enrolled within 3 months of the acute ischaemic stroke.
  • Inclusion criteria includes patients with:
  • Patient consent or advice given by consultee can be obtained
  • Confirmed acute ischaemic stroke with evidence on brain CT and/or MRI within 3 months of study enrolment • Ischaemic stroke of unknown source Expected survival >12 months.
  • At least one additional stroke risk factor (i.e. CHA2DS2VASc>=3)
  • Sinus rhythm on 12 lead ECG, telemetry and a regular pulse on clinical examination
  • Above 18 years of age

排除标准

  • Unable to obtain patient consent or advice by consultee
  • History of atrial fibrillation
  • Atrial fibrillation detected on ECG and/or telemetry (AF duration of at least 30 seconds required for diagnosis)
  • eGFR <30ml/min
  • Indication for pacemaker/implantable cardioverter-defibrillator
  • Contra-indication to undergo cardiac MRI (e.g. severe claustrophobia, unable to lie flat for prolonged period, contrast allergy)
  • Carotid stenosis >50% on Duplex ultrasound associated with anterior circulation infarction
  • Vertebrobasilar stenosis >50% on CT/MR angiography associated with posterior circulation infarction
  • Single, isolated lacunar stroke with a corresponding lacunar infarct on brain CT/MRI
  • Specific aetiology for cause of stroke (e.g. arteritis, dissection, drug abuse)

结局指标

主要结局

AF Predictors

时间窗: 1 year

Determine if atrial CMR imaging can predict the occurrence of atrial fibrillation in advance of the clinical arrhythmia in patients with confirmed ischaemic stroke

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验