Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

Atrial Fibrillation Clinical Trial

— CAMS-AF  

Official title:

Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05217485
• Other study ID #: CAMSAF
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: March 2024

Study information

• Verified date: January 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To detect atrial fibrillation after infection.

Description:

This study will prospectively recruit patients who are admitted to CUH general medical wards due to an infection or sepsis and develop new/first diagnosed transient AF. In CUH, our previous projects have shown that around 1500 patients are admitted under general medicine each month at least 1 new diagnosis of AF is made each day (30/month)26. In particular to the cohort that develop sepsis, they may well be frail and elderly where anticoagulation is often not prescribed as a result 27 unless definitive diagnosis of recurrent AF would be made. The CAMS-AF study will closely tie in with an already existing stroke prevention service at CUH (SOS-AF) who are already screening for patient admitted with AF on general medical wards and will therefore be able to identify those with new AF during an episode of sepsis. Potential participants will be approached by the study investigators prior to discharge and if they are in sinus rhythm written consent will be obtained to place a non-invasive wearable cardiac monitor patch for 14-days, to detect any subclinical arrhythmias, particularly AF.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18
• Admission with any infection or sepsis
• Transient AF
• Under general medicine
• Can be anticoagulated or not
• Sinus rhythm at discharge or point of Zio patch placement

Exclusion Criteria:

• Previous history of AF or paroxysmal AF
• Age less than 18 years
• Pregnancy
• Active and known malignancy
• Recent cardiac or non-cardiac surgery (3 months)
• Recent myocardial infarction (3 months)
• Individuals with skin allergies to plasters and adhesive devices
• Chest wall deformity, skin condition over sticker site
• History of thyroid disease
• Current alcohol intake above recommended limits
• Already has a cardiac monitor or pacemaker inserted
• Known contraindication for anticoagulation therapy
• Patients who lack capacity or have an estimated life expectancy < 1 year

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia
• Infections
• Sepsis
• Toxemia

Intervention

Device:
• Zio 14-day cardiac patch
A wearble adhesive cardiac patch (14-day) called Zio

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the incidence of early (within 14-days) AF recurrence in patients who are being discharged, following hospitalisation for an infection or sepsis and develop transient AF at CUH.		12 months