Clinical trial NCT05217485: Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
Official title: Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Sepsis
Infections
Cardiac Arrhythmia
Keywords: atrial fibrillation
sepsis
anticoagulation
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2022-02-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional single arm, prospective cohort
Primary purpose: DIAGNOSTIC

Brief summary: To detect atrial fibrillation after infection.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
Study officials:
References: