NCT04555538

Atrial CMR in Patients With CVA of Unknown Source and no Known AF

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke, Ischemic
• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac MRI	These are routinely performed for many cardiac conditions, including atrial arrhythmias. The adverse effects are small but include claustrophobia and metallic objects. Therefore all patients will be counselled prior to the scans by an experienced MRI practitioner and standard measures will be taken to avoid distress during the scan. Furthermore, patients will be screened using routine clinical protocols in order to avoid any harm due to interaction of the MRI scanner with metallic objects.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2020-09-18
• Last updated: 2021-05-03

Locations

3 sites across 1 country: United Kingdom