Atrial FibrillationCAMS-AFNCT05217485
Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
A study testing Zio 14-day cardiac patch in people with Atrial Fibrillation and Sepsis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To detect atrial fibrillation after infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Sepsis, Infections
- What is being tested?
- Zio 14-day cardiac patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0QQ
About this study
To detect atrial fibrillation after infection.
Read the 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
- Being tested
- Zio 14-day cardiac patch
- Keywords
- atrial fibrillation, sepsis, anticoagulation
- Medical subject headings
- Atrial Fibrillation, Sepsis, Infections, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zio 14-day cardiac patchDevice
A wearble adhesive cardiac patch (14-day) called Zio
| Study group | Role | What they receive |
|---|---|---|
| Infection and reverted atrial fibrillation | Experimental | Patients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection Receives: Device: Zio 14-day cardiac patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional single arm, prospective cohort
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Isuru Induruwa, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217485
- Sponsor's protocol ID
- CAMSAF
- Acronym
- CAMS-AF
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis
- ClinicalTrials.gov ID
- NCT05217485
- Acronym / sponsor ID
- CAMS-AF / CAMSAF
- Conditions
- Atrial Fibrillation, Sepsis, Infections, Cardiac Arrhythmia
- Keywords
- atrial fibrillation, sepsis, anticoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional single arm, prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Infection and reverted atrial fibrillation | Experimental | Device: Zio 14-day cardiac patchPatients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18
- Admission with any infection or sepsis
- Transient AF
- Under general medicine
- Can be anticoagulated or not
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zio 14-day cardiac patchA wearble adhesive cardiac patch (14-day) called Zio | Device | Infection and reverted atrial fibrillation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zio 14-day cardiac patch in people with Atrial Fibrillation and Sepsis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.