Preventing Recurrent Cardioembolic Stroke (The PRECISE Study)

NCT06767189 | Active Not Recruiting

• 1 other identifier: GN21ST183
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 3

Brief Summary

Heart rhythm monitors are worn for 3 days after a stroke to look for an abnormal heart rhythm called atrial fibrillation (AF) that increases the risk of blood clots and second strokes. If AF is found, then blood thinning drugs called anticoagulants can greatly reduce the chance of a second stroke. However, there are often long waits for these tests to be done and only 4 out of every 100 people who have a 3 day heart rhythm monitor are found to have AF. New heart rhythm monitors that are worn for longer find many more people with AF, but these tests are expensive and are not needed for all people after stroke. It has also been difficult to implement them in the NHS as a lot of time and resource is spent trying to perform 3 day heart rhythm monitors. A solution is to identify people who are very unlikely to have AF after stroke and who do not need heart rhythm monitors for 3 days or longer. This will free resources to allow longer heart rhythm monitors to be focused on people who are more likely to have AF and benefit. We aim to develop a risk score that highlights people who are unlikely to have AF after stroke, and who do not need heart rhythm monitors for 3 days or longer. We will use the risk score to develop a more personalised care pathway to look for AF after stroke that could reduce testing for many people after stroke. This would allow higher risk people to benefit from longer cardiac monitoring, increase AF detection rates and allow more people to benefit from anticoagulant drugs to prevent second strokes. We will recruit 675 people admitted to hospital with a stroke who are not known to have AF. We will collect clinical information, heart rhythm recordings performed at rest (electrocardiograms/ECGs) and a blood to measure levels of the blood markers MRproANP, NTproBNP and genetic information. Everyone will have a 28 day heart rhythm monitor to search for AF. We will analyse the clinical information, ECG recordings, MRproANP/NTproBNP levels and genetic data to develop a risk score that highlights people who do not have AF after 30 days of heart rhythm monitoring. We will use the risk score to develop a more personalised care pathway to search for AF after stroke that reduces the number of 3 day heart rhythm monitors performed and frees resources to focus longer heart rhythm monitoring on higher risk people who are more likely to benefit. We will assess the potential impact on healthcare costs of adopting this approach by estimating the number of second strokes that could be prevented by increased use of anticoagulant drugs for people who are found at have AF.

Conditions

Stroke; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation

  AF Detection

  1 year

Interventions

ECG monitoring DIAGNOSTIC_TEST

R-test or ECG patch for up to 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People admitted to hospital with acute ischaemic stroke or TIA who are not known to have AF and who would be suitable for treatment with anticoagulant drugs if AF is found.

You may qualify if:

• Age \> 18 years Admitted with acute ischaemic stroke or TIA in the 5 days prior to enrolment No known AF Venous blood sampling possible Able to provide informed consent

You may not qualify if:

• Contraindication to oral anticoagulant therapy

Sponsors & Collaborators

• University of Glasgow: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (3)

NHS Lothian

Dundee, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

NHS Lanarkshire

Glasgow, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 9, 2025
• Study Start: August 3, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

GB (3)