Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

NCT ID: NCT05217485

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-03-31

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.

Conditions

Atrial Fibrillation; Sepsis; Infections; Cardiac Arrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Infection and reverted atrial fibrillation

Patients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection

Group Type: EXPERIMENTAL

Zio 14-day cardiac patch

Intervention Type: DEVICE

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

Interventions

Zio 14-day cardiac patch

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Isuru Induruwa

Clinical Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cambridge University Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

CAMSAF

Identifier Type: -

Identifier Source: org_study_id