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

Primary Purpose

Atrial Fibrillation, Sepsis, Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Zio 14-day cardiac patch
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring atrial fibrillation, sepsis, anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cambridge University Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infection and reverted atrial fibrillation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2022
Last Updated
January 20, 2022
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT05217485
Brief Title
Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
Acronym
CAMS-AF
Official Title
Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Sepsis, Infections, Cardiac Arrhythmia
Keywords
atrial fibrillation, sepsis, anticoagulation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional single arm, prospective cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infection and reverted atrial fibrillation
Arm Type
Experimental
Arm Description
Patients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection
Intervention Type
Device
Intervention Name(s)
Zio 14-day cardiac patch
Intervention Description
A wearble adhesive cardiac patch (14-day) called Zio
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cambridge University Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

Learn more about this trial

Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

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