Tracking Atrial Fibrillation After Intensive Care Admission

NCT05229211 | Recruiting FDA Device

• 1 other identifier: PID291237
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart's ability to pump blood around the body efficiently, causing heart failure. It also increases the risk of blood clots forming inside the heart. These clots may then be pumped out of the heart, through the blood vessels, to other parts of the body. This can cause strokes if the clots spread to the brain. AF is a common problem outside an Intensive Care Unit (ICU), where treatment is based on good, evidence-based guidelines designed to reduce the risk of problems like heart failure or strokes. Around 10% of patients treated in ICU develop atrial fibrillation as a complication of their underlying illness. Some patients will recover their normal heart rhythm before leaving the ICU, often with the help of some medical treatments. It is not known whether these patients will get AF again after leaving the ICU, or when this is likely to happen. It is also unknown whether patients who avoid AF whilst on the ICU may still be at high risk of developing it after they leave. This study will identify patients on the ICU who have no previous record of atrial fibrillation. These patients will be monitored whilst on the ICU to identify those who develop AF. Those patients who develop new onset AF will be monitored on the ward after leaving the ICU to see which patients have AF at this point. The heart monitoring will be repeated once the patients leave hospital, again to identify whether they have atrial fibrillation. Some studies suggest that AF during critical illness causes a long-term risk of recurrent AF and AF associated complications such as heart failure, stroke, and death. To understand how to minimise these risks in intensive care patients, we need to know how which patients who develop atrial fibrillation whilst in an ICU go on to have recurrent atrial fibrillation in hospital and in the community. These patients may benefit from interventions to reduce long term adverse events such as anticoagulation to reduce stroke risk.

Conditions

Atrial Fibrillation New Onset; New Onset Atrial Fibrillation; Atrial Fibrillation

Keywords

Critical illness; Intensive care; Atrial fibrillation; Outcomes

Outcome Measures

Primary Outcomes (3)

• Proportion of eligible patients who are willing to participate in the study

  3 months post hospital discharge

• Proportion of patients who are compliant with the study protocol

  3 months post hospital discharge

• Proportion of patients lost to follow up

  3 months post hospital discharge

Secondary Outcomes (9)

• Proportion of patients who are in AF post ICU discharge in hospital.

  14 days post ICU hospital discharge

• Proportion of patients who are in AF at 3 months post hospital discharge

  3 months post hospital discharge

• Proportion of patients who develop NOAF in ICU who develop stroke or TIA post ICU discharge

  14 days post ICU discharge

• Proportion of patients who develop NOAF in ICU who develop stroke or TIA post hospital discharge

  3 months post hospital discharge

• Difference in hospital length of stay in patients who develop atrial fibrillation after ICU discharge compared to patients who do not.

  Follow up patient appointment at 3 months post hospital discharge.

Other Outcomes (2)

• Proportion of AF episodes detected compared to a. Validated CE marked algorithm b. Compared to 3 best-in-class algorithms

  3 months post hospital discharge

• Identify subgroups of patients that are at increased risk of adverse outcomes of new onset atrial fibrillation in ICU compared to those who are not.

  At completion of study at 3 months post hospital discharge.

Study Arms (1)

New Onset Atrial Fibrillation

Patients admitted to an adult intensive care unit for more than 24 hours who develop new onset atrial fibrillation during their ICU admission will be included. After discharge from ICU patients will undergo continuous ECG monitoring via VitalConnect patch for 14 days or until hospital discharge, whichever is shortest. They will undergo a further 7 days of continuous ECG monitoring via VitalConnect patch as an outpatient at 3 months post hospital discharge.

Device: Cardiac monitoring

Interventions

Cardiac monitoring DEVICE

Continuous ECG monitoring via VitalConnect patch worn on the chest.

Also known as: VitalConnect patch

New Onset Atrial Fibrillation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an intensive care unit for more than twenty four hours who were not known to have atrial fibrillation prior to admission.

You may qualify if:

• Willing and able to give informed consent for participation in the study, or favourable consultee advice for adults lacking capacity
• Male or Female,
• aged 16 years or above.
• Admitted to intensive care for \>24 hours
• New onset atrial fibrillation as confirmed by 12 lead ECG-

You may not qualify if:

• History of atrial fibrillation
• Unable to undergo cardiac monitoring
• Previously included in the study
• Not anticipated by treating consultant to survive to ICU discharge (withdrawal or limitation of medical treatment at time of screening)
• Contraindication to anticoagulation
• Unable to wear the device for the prescribed monitoring period
• Implanted neurostimulator, as this may disrupt the ECG recording

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Critical Illness

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Peter Watkinson, MD.

CONTACT

01865231448; ccrg.research@ndcn.ox.ac.uk@ndcn.ox.ac.uk

Rachel Henning

CONTACT

01865231448; ccrg.research@ndcn.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 8, 2022
• Study Start: February 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

GB (1)