Improving AF Detection in Cryptogenic Stroke

Status Recruiting

Clinical Trial Summary

No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy. A randomised controlled study in 2014 showed that whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Prolonged monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields. The Apple Watch (AW) is a wristwatch able to monitor a wearer's heart rate and rhythm regularity and facilitates real- time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05007847
Study type	Interventional
Source	Barts & The London NHS Trust
Contact	Richard Schilling
Phone	02037658635
Email	richard.schilling@nhs.net
Status	Recruiting
Phase	N/A
Start date	February 4, 2022
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Completed	`NCT04571385` - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)	Phase 2
Completed	`NCT05366803` - Women's Health Initiative Silent Atrial Fibrillation Recording Study	N/A
Completed	`NCT02864758` - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting	`NCT05442203` - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease	N/A
Completed	`NCT05599308` - Evaluation of Blood Pressure Monitor With AFib Screening Feature	N/A
Completed	`NCT03790917` - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation	`NCT05890274` - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO	N/A
Recruiting	`NCT05316870` - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation	N/A
Recruiting	`NCT05266144` - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting	`NCT06023784` - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT04087122` - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures	N/A
Completed	`NCT06283654` - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04546763` - Study Watch AF Detection At Home
Completed	`NCT03761394` - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving AF Detection in Cryptogenic Stroke — CSAF-AW

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms