NCT04555538

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 3, 2021

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

September 14, 2020

Last Update Submit

April 28, 2021

Conditions

Stroke, IschemicAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF Predictors

    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

Study Arms (2)

Atrial Fibrillation Group

Diagnostic Test: Cardiac MRI

Non-Atrial Fibrillation Group

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRIDIAGNOSTIC_TEST

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.

Atrial Fibrillation GroupNon-Atrial Fibrillation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited during outpatient clinics and inpatient stays

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Guy's and St Thomas' Hospital

London, United Kingdom

RECRUITING

King's College Hospital

London, United Kingdom

NOT YET RECRUITING

Princess Royal University Hospital

Orpington, United Kingdom

RECRUITING

Related Publications (1)

  • Kotadia ID, O'Dowling R, Aboagye A, Crawley RJ, Bodagh N, Gharaviri A, O'Hare D, Solis-Lemus JA, Roney CH, Sim I, Ramsey D, Newby D, Chiribiri A, Plein S, Sztriha L, Scott P, Masci PG, Harrison J, Williams MC, Birns J, Somerville P, Bhalla A, Niederer S, O'Neill M, Williams SE. High Prevalence of New Clinically Significant Findings in Patients With Embolic Stroke of Unknown Source Evaluated by Cardiac Magnetic Resonance Imaging. J Am Heart Assoc. 2024 Feb 6;13(3):e031489. doi: 10.1161/JAHA.123.031489. Epub 2024 Jan 19.

    PMID: 38240222DERIVED

MeSH Terms

Conditions

Ischemic StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Williams, MBChB PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irum D Kotadia, BSc MBBS

CONTACT

02071887188irum.kotadia@kcl.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

October 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

May 3, 2021

Record last verified: 2020-10

Locations

GB(3)