NCT04555538: CARM-AF

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

Status unknown Last updated 3 May 2021

What this trial tests

trial testing Cardiac MRI in Stroke, Ischemic in 92 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
1 August 2022

1 August 2023

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	92
Start date	1 October 2020
Primary completion	1 August 2022
Estimated completion	1 August 2023
Sites	3 locations across United Kingdom

Drugs / interventions tested

• Cardiac MRI

Conditions studied

• Stroke, Ischemic — all drugs for Stroke, Ischemic →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

18 and older, any sex, with Stroke, Ischemic or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. High Prevalence of New Clinically Significant Findings in Patients With Embolic Stroke of Unknown Source Evaluated by Cardiac Magnetic Resonance Imaging.
   Kotadia ID, O'Dowling R, Aboagye A, Crawley RJ, et al · · 2024 · cited 2× · PMID 38240222 · DOI 10.1161/jaha.123.031489