Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis (CAMS-AF)

January 20, 2022 updated by: Isuru Induruwa, Cambridge University Hospitals NHS Foundation Trust
To detect atrial fibrillation after infection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infection and reverted atrial fibrillation
Patients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection
Device: Zio 14-day cardiac patch
A wearble adhesive cardiac patch (14-day) called Zio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMSAF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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