Stroke, IschemicCARM-AFNCT04555538
Atrial CMR in Patients With CVA of Unknown Source and no Known AF
An observational study of Stroke, Ischemic and Atrial Fibrillation, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Atrial Fibrillation
- What is being tested?
- Cardiac MRI
- How many people
- 92 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Oct 2020to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited during outpatient clinics and inpatient stays
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Guy's and St Thomas' Hospital
London
Irum Kotadia, MBBS, BSc, irum.kotadia@kcl.ac.uk
- Not yet recruiting
King's College Hospital
London
James Harrison
- Recruiting
Princess Royal University Hospital
Orpington
James Harrison
About this study
Official title: 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.
Read more
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
- Being tested
- Cardiac MRI
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation Group | Not described Receives: Diagnostic Test: Cardiac MRI | |
| Non-Atrial Fibrillation Group | Not described Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, King's College London, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Steven Williams, MBChB PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555538
- Sponsor's protocol ID
- 269654
- Acronym
- CARM-AF
- Status last verified
- Oct 2020
- First submitted
- 14 Sep 2020
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38240222
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Cardiac Magnetic Resonance Imaging in Patients With Embolic Stroke of Unknown Source Without Documented Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04555538
- Acronym / sponsor ID
- CARM-AF / 269654
- Conditions
- Stroke, Ischemic, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, King's College London, British Heart Foundation
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Group | – | Diagnostic Test: Cardiac MRI |
| Non-Atrial Fibrillation Group | – | Diagnostic Test: Cardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during outpatient clinics and inpatient stays
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIThese 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. | Diagnostic test | Atrial Fibrillation Group, Non-Atrial Fibrillation Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 38240222Kotadia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Williams, MBChB PhD principal investigator
King's College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Atrial Fibrillation, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irum D Kotadia, BSc MBBS (02071887188, irum.kotadia@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF Predictors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.