Atrial CMR in Patients With CVA of Unknown Source and no Known AF (CARM-AF)
Atrial Cardiac Magnetic Resonance Imaging in Patients With Embolic Stroke of Unknown Source Without Documented Atrial Fibrillation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Irum D Kotadia, BSc MBBS
- Phone Number: 02071887188
- Email: irum.kotadia@kcl.ac.uk
Study Locations
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-
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London, United Kingdom
- Not yet recruiting
- King's College Hospital
-
Contact:
- James Harrison
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London, United Kingdom
- Recruiting
- Guy's and St Thomas' Hospital
-
Contact:
- Irum Kotadia, MBBS, BSc
- Email: irum.kotadia@kcl.ac.uk
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Orpington, United Kingdom
- Recruiting
- Princess Royal University Hospital
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Contact:
- James Harrison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Atrial Fibrillation Group
|
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.
|
|
Non-Atrial Fibrillation Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AF Predictors
Time Frame: 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
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Williams, MBChB PhD, King's College London
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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