Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

March 3, 2021 updated by: University College, London
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5601803

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

  • Individuals are excluded if they had a prior history of AF before study entry.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Atrial fibrillation
Time Frame: Jan 1st 1998 - May 31st 2016
AF incidence in the population
Jan 1st 1998 - May 31st 2016
Mortality of Atrial fibrillation
Time Frame: Jan 1st 1998 - May 31st 2016
Mortality among AF patients
Jan 1st 1998 - May 31st 2016

Collaborators and Investigators

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

Sponsor

University College, London

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 (Actual)

January 1, 1998

Primary Completion (Actual)

May 31, 2016

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISAC17_205

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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