Atrial FibrillationCONSIDERING-AFNCT05838781
DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation
A study testing Risk prediction model and 14-days continuous ECG monitoring in people with Atrial Fibrillation and Atrial Flutter, run by Bristol-Myers Squibb at 2 sites in Sweden.
Trial summary
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Risk prediction model and 14-days continuous ECG monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,112 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Dec 2023to 16 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Alive residents in the Halland region aged 65 or older without a recorded diagnosis of AF
Who cannot join
- Known atrial fibrillation
- Death
- No longer resident in Region Halland
- Pacemaker, implantable cardioverter defibrillator or insertable monitor
- Dementia
- Other indication for OAC treatment (such as VTE, mechanical heart valve replacement, VTE prophylaxis post surgery, mitral stenosis, left side intracardial thrombus)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet Danderyd University Hospital
Stockholm, Outside US, 18288
Halland Hospital Varberg
Varberg, Outside US, 43281
About this study
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. It is important to find patients with AF and additional risk factors for stroke in order to initiate oral anticoagulation treatment, which can reduce the risk of an ischaemic stroke by 60-70%. Screening is recommended in European guidelines, however the most suitable population and the most suitable device for AF detection remain to be defined.
The main objective of this study is to test the hypothesis that AF screening with 14-days continuous ECG monitoring in high-risk individuals identified with a risk prediction model is more effective than routine care in identifying patients with undetected AF.
Effectively detecting AF among patients with risk factors for ischaemic stroke has the potential to decrease mortality and morbidity, stroke burden and costs for the society as a whole.
Read the detailed description
Objective(s): To compare the yield of atrial fibrillation (AF) using 14-days continuous ECG in a population aged ≥ 65 years with an increased risk for AF incidence according to the risk prediction model compared with standard of care in Region Halland.
Study Population: Residents in Region Halland age 65 and above.
Data Collection Methods: Electronic Health Records from Region Halland and 14-days continuous ECG recording using an ECG patch.
Study design:
Step 1:
To calibrate the BMS/Pfizer risk prediction model (RPM), we will extract two cohorts retrospectively: the AF cohort with an AF diagnosis (patients with a record of incident AF diagnosis between January 1, 2016, and December 31, 2019 as an observation period), and the control cohort without any AF diagnosis in their history. We will include patients ≥45 years of age at index date, which is the first date of an AF diagnosis recorded in the observation period and a random pseudo index date during the observation period for the control group, to follow the original study. Specifically, we are looking to calibrate the intercept (α) for the logistic regression where we already have the 13 odd ratios for the 13 risk factors from the original study. Then in the next step for the prospective study, applying the RPM on the RPM cohort, the at-risk group will be extracted for randomization step, using the recommended cut-off value.
Step 2:
The population in Region Halland aged 65 years and above and free from AF will be randomized into two halves, creating a general cohort and an RPM cohort. In the general cohort, 1480 individuals will be further randomized into two arms, general/control and general/intervention. In the RPM cohort, the risk of incident AF will be calculated according to the Pfizer/BMS RPM. Those with a predicted risk for incident AF above a pre-specified threshold will then be randomly extracted into two arms, RPM/control and RPM/intervention (figure 1).
Those randomized to the two intervention arms (general/intervention and RPM/intervention, n=740 each) will be invited to an AF screening intervention of 14-days continuous ECG using a patch device. Those randomized to the control groups (general/control and RPM/control, n=740 each) will not receive any information or intervention.
The primary endpoint will be the difference in yield of newly diagnosed AF between the RPM/intervention and the general/control arms, where the latter will represent standard of care. Participants with newly diagnosed AF in the intervention arms will be offered consultation aiming at AF work-up and initiation of oral anticoagulation treatment.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Risk prediction model, 14-days continuous ECG monitoring
- Keywords
- Atrial Fibrillation, Atrial Flutter, Mass Screening
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk prediction modelDiagnostic test
A risk prediction model (RPM) based on logistic regression. The RPM uses 13 variables accessible in healthcare registers to identify individuals with high future risk for developing AF. ICD-10 codes will be used.
14-days continuous ECG monitoringDiagnostic test
14-days continuous ECG monitoring with an ECG patch.
| Study group | Role | What they receive |
|---|---|---|
| General/control | No intervention | Standard of care. |
| General/intervention | Experimental | Standard of care plus 14-days continuous ECG monitoring using an ECG patch. Receives: Diagnostic Test: 14-days continuous ECG monitoring |
| Risk prediction model/control | Experimental | Standard of care. Receives: Diagnostic Test: Risk prediction model |
| Risk prediction model/intervention | Experimental | Standard of care plus 14-days continuous ECG monitoring using an ECG patch. Receives: Diagnostic Test: Risk prediction model; Diagnostic Test: 14-days continuous ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident AF
- Incident AF on ECG screening (intervention arms) defined as at least one episode of AF or atrial flutter with a duration of at least 30 seconds on ambulatory ECG recording.
- Incident AF registered in the Electronic Health Record during follow-up (all four arms).
Measured: 14 days
Secondary outcomes (3)
Yield newly diagnosed AF: RPM/ intervention arm versus RPM/ control arm
To compare the yield of newly diagnosed AF using 14-days continuous ECG in a population aged ≥ 65 years with an increased risk for AF incidence according to the RPM compared with a population with increased risk according to the RPM without intervention.
Measured: 14 days
Yield newly diagnosed AF: general/ intervention arm versus RPM/ control arm
To compare the yield of newly diagnosed AF using 14-days continuous ECG in a general population aged ≥ 65 years compared with a population with increased risk according to the RPM without intervention.
Measured: 14 days
Yield newly diagnosed AF: general/ intervention arm versus general/ control arm
To compare the yield of newly diagnosed AF using 14-days continuous ECG in a general population aged ≥ 65 years compared with a general population without intervention.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 Dec 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- Siteless, randomized, 2x2 factorial design, superiority trial
- Masking
- None (open label)
- Enrolment
- 2,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Region Halland, Halmstad University, Karolinska Institutet, Pfizer, Philips Healthcare
- Responsible party
- Principal investigator, Johan Engdahl, MD, Bristol-Myers Squibb
- Investigators
- Johan Engdahl, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838781
- Sponsor's protocol ID
- CV185-837
- Acronym
- CONSIDERING-AF
- Status last verified
- May 2024
- First submitted
- 20 Apr 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Etminani F, Sandgren E, Holm J, Magnusson P, Modica A, Moberg K, Davidsson T, Stalpe L, Kiflemariam S, Younan N, Parikh P, Wadhwa M, Sundin A, Engdahl J. Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >/= 65 years: CONSIDERING-AF study design. BMJ Open. 2024 Jan 12;14(1):e080639. doi: 10.1136/bmjopen-2023-080639.
PubMed 38216189
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05838781
- Acronym / sponsor ID
- CONSIDERING-AF / CV185-837
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial Fibrillation, Atrial Flutter, Mass Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,112 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Region Halland, Halmstad University, Karolinska Institutet, Pfizer, Philips Healthcare
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 3 May 2023 (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.
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. It is important to find patients with AF and additional risk factors for stroke in order to initiate oral anticoagulation treatment, which can reduce the risk of an ischaemic stroke by 60-70%. Screening is recommended in European guidelines, however the most suitable population and the most suitable device for AF detection remain to be defined.
The main objective of this study is to test the hypothesis that AF screening with 14-days continuous ECG monitoring in high-risk individuals identified with a risk prediction model is more effective than routine care in identifying patients with undetected AF.
Effectively detecting AF among patients with risk factors for ischaemic stroke has the potential to decrease mortality and morbidity, stroke burden and costs for the society as a whole.
Detailed description
Objective(s): To compare the yield of atrial fibrillation (AF) using 14-days continuous ECG in a population aged ≥ 65 years with an increased risk for AF incidence according to the risk prediction model compared with standard of care in Region Halland.
Study Population: Residents in Region Halland age 65 and above.
Data Collection Methods: Electronic Health Records from Region Halland and 14-days continuous ECG recording using an ECG patch.
Study design:
Step 1:
To calibrate the BMS/Pfizer risk prediction model (RPM), we will extract two cohorts retrospectively: the AF cohort with an AF diagnosis (patients with a record of incident AF diagnosis between January 1, 2016, and December 31, 2019 as an observation period), and the control cohort without any AF diagnosis in their history. We will include patients ≥45 years of age at index date, which is the first date of an AF diagnosis recorded in the observation period and a random pseudo index date during the observation period for the control group, to follow the original study. Specifically, we are looking to calibrate the intercept (α) for the logistic regression where we already have the 13 odd ratios for the 13 risk factors from the original study. Then in the next step for the prospective study, applying the RPM on the RPM cohort, the at-risk group will be extracted for randomization step, using the recommended cut-off value.
Step 2:
The population in Region Halland aged 65 years and above and free from AF will be randomized into two halves, creating a general cohort and an RPM cohort. In the general cohort, 1480 individuals will be further randomized into two arms, general/control and general/intervention. In the RPM cohort, the risk of incident AF will be calculated according to the Pfizer/BMS RPM. Those with a predicted risk for incident AF above a pre-specified threshold will then be randomly extracted into two arms, RPM/control and RPM/intervention (figure 1).
Those randomized to the two intervention arms (general/intervention and RPM/intervention, n=740 each) will be invited to an AF screening intervention of 14-days continuous ECG using a patch device. Those randomized to the control groups (general/control and RPM/control, n=740 each) will not receive any information or intervention.
The primary endpoint will be the difference in yield of newly diagnosed AF between the RPM/intervention and the general/control arms, where the latter will represent standard of care. Participants with newly diagnosed AF in the intervention arms will be offered consultation aiming at AF work-up and initiation of oral anticoagulation treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Siteless, randomized, 2x2 factorial design, superiority trial
| Arm | Type | Receives |
|---|---|---|
| General/control | No intervention | –Standard of care. |
| General/intervention | Experimental | Diagnostic Test: 14-days continuous ECG monitoringStandard of care plus 14-days continuous ECG monitoring using an ECG patch. |
| Risk prediction model/control | Experimental | Diagnostic Test: Risk prediction modelStandard of care. |
| Risk prediction model/intervention | Experimental | Diagnostic Test: Risk prediction model, Diagnostic Test: 14-days continuous ECG monitoringStandard of care plus 14-days continuous ECG monitoring using an ECG patch. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Alive residents in the Halland region aged 65 or older without a recorded diagnosis of AF
Key exclusion criteria (6 listed)
- Known atrial fibrillation
- Death
- No longer resident in Region Halland
- Pacemaker, implantable cardioverter defibrillator or insertable monitor
- Dementia
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 |
|---|---|---|
| Risk prediction modelA risk prediction model (RPM) based on logistic regression. The RPM uses 13 variables accessible in healthcare registers to identify individuals with high future risk for developing AF. ICD-10 codes will be used. | Diagnostic test | Risk prediction model/control, Risk prediction model/intervention |
| 14-days continuous ECG monitoring14-days continuous ECG monitoring with an ECG patch. | Diagnostic test | General/intervention, Risk prediction model/intervention |
Primary outcome
Incident AF
Time frame: 14 days
1. Incident AF on ECG screening (intervention arms) defined as at least one episode of AF or atrial flutter with a duration of at least 30 seconds on ambulatory ECG recording. 2. Incident AF registered in the Electronic Health Record during follow-up (all four arms).
3 secondary outcomes
Yield newly diagnosed AF: RPM/ intervention arm versus RPM/ control arm
Time frame: 14 days
Yield newly diagnosed AF: general/ intervention arm versus RPM/ control arm
Time frame: 14 days
Yield newly diagnosed AF: general/ intervention arm versus general/ control arm
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 38216189Etminani F, Sandgren E, Holm J, Magnusson P, Modica A, Moberg K, Davidsson T, Stalpe L, Kiflemariam S, Younan N, Parikh P, Wadhwa M, Sundin A, Engdahl J. Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >/= 65 years: CONSIDERING-AF study design. BMJ Open. 2024 Jan 12;14(1):e080639. doi: 10.1136/bmjopen-2023-080639.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
Johan Engdahl, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk prediction model and 14-days continuous ECG monitoring in people with Atrial Fibrillation and Atrial Flutter, run by Bristol-Myers Squibb at 2 sites in Sweden.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident AF (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838781, which also lists 1 linked publication.
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 22 May 2024.