Atrial FibrillationNCT04786366
Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
An observational study of Atrial Fibrillation and Epidemiology, run by University College, London.
Trial summary
The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Epidemiology
- What is being tested?
- The study does not have an intervention, but observe the AF incidence of the UK disease-free population
- How many people
- 5,601,803 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1998to 30 Jun 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The investigators implement two study designs, first a longitudinal cohort study to assess AF incidence and second a matched case-control study for mortality, cause of death and hospitalization. The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of AF before study entry. For the nested case-control study, controls are matched to incident AF patients according to sex and age (10-year age strata).
Who may be able to join
- The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.
Who cannot join
- Individuals are excluded if they had a prior history of AF before study entry.
About this study
The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.
- Conditions
- Atrial Fibrillation, Epidemiology
- Being tested
- The study does not have an intervention, but observe the AF incidence of the UK disease-free population
- Keywords
- Atrial Fibrillation, healthcare contacts, Electronic Health Records, epidemiology, comorbidity, health inequality
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study does not have an intervention, but observe the AF incidence of the UK disease-free populationOther
The study does not have an intervention, but observe the AF incidence of the UK disease-free population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial fibrillation
AF incidence in the population
Measured: Jan 1st 1998 - May 31st 2016
Mortality of Atrial fibrillation
Mortality among AF patients
Measured: Jan 1st 1998 - May 31st 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jan 1998
- Primary completion31 May 2016
- Study completion30 Jun 2021 (estimated)
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 University College, LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,601,803 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786366
- Sponsor's protocol ID
- ISAC17_205
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung SC, Schmit AF, Lip GYH, Providencia R. Electronic health record-wide association study for atrial fibrillation in a British cohort. Front Cardiovasc Med. 2023 Sep 28;10:1204892. doi: 10.3389/fcvm.2023.1204892. eCollection 2023.
PubMed 37840952
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
- ClinicalTrials.gov ID
- NCT04786366
- Acronym / sponsor ID
- ISAC17_205
- Conditions
- Atrial Fibrillation, Epidemiology
- Keywords
- Atrial Fibrillation, healthcare contacts, Electronic Health Records, epidemiology, comorbidity, health inequality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,601,803 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 8 Mar 2021 (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.
The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators implement two study designs, first a longitudinal cohort study to assess AF incidence and second a matched case-control study for mortality, cause of death and hospitalization. The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of AF before study entry. For the nested case-control study, controls are matched to incident AF patients according to sex and age (10-year age strata).
Key inclusion criteria (1 listed)
- The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.
Key exclusion criteria (1 listed)
- Individuals are excluded if they had a prior history of AF before study entry.
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 |
|---|---|---|
| The study does not have an intervention, but observe the AF incidence of the UK disease-free populationThe study does not have an intervention, but observe the AF incidence of the UK disease-free population. | Other | – |
Primary outcome
Incidence of Atrial fibrillation
Time frame: Jan 1st 1998 - May 31st 2016
AF incidence in the population
Mortality of Atrial fibrillation
Time frame: Jan 1st 1998 - May 31st 2016
Mortality among AF patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 37840952Chung SC, Schmit AF, Lip GYH, Providencia R. Electronic health record-wide association study for atrial fibrillation in a British cohort. Front Cardiovasc Med. 2023 Sep 28;10:1204892. doi: 10.3389/fcvm.2023.1204892. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Epidemiology, run by University College, London.
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 1 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Atrial fibrillation (time frame: Jan 1st 1998 - May 31st 2016). The study lists 2 primary outcomes in all. 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 NCT04786366, 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 8 Mar 2021.