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A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
St Bartholomews and The Royal London Hospital
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01944397
First received: September 12, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation to the development of subsequent stroke, heart failure, and myocardial infarction. We will explore the relationship between these outcomes and a range of risk factors.


Condition
Atrial Fibrillation
Heart Failure
Stroke
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for the Development of Stroke, Heart Failure, and Myocardial Infarction in Patients Diagnosed With Atrial Fibrillation: a CALIBER Study

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Stroke (ischaemic, haemorrhagic, and NOS) [ Time Frame: Throughout follow-up (maximum 12 years) ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: Throughout follow-up (maximum 12 years) ] [ Designated as safety issue: No ]
  • Heart failure [ Time Frame: Throughout follow-up (maximum 12 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ] [ Designated as safety issue: No ]
  • Cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ] [ Designated as safety issue: No ]
    Excluding heart failure, myocardial infarction, stroke


Estimated Enrollment: 125000
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Atrial fibrillation
Patients with a diagnosis of atrial fibrillation recorded in primary or secondary care during the study period.

Detailed Description:

The development of stroke in AF patients continues to be an area of substantial research focus. However, comparatively little research has investigated the extent to which HF and MI also make a substantial contribution to morbidity and mortality in this patient group, and whether there is overlap in the prognostic factors associated development of stroke, HF, and MI.

Conen et al. demonstrated that mortality risk in AF patients is partly mediated by the development of non-fatal stroke, HF, and MI. However, they did not investigate differences in the cumulative incidence of these conditions between different patient groups (e.g. men and women), or the relationship between potential prognostic factors and the development of these conditions. Sets of prognostic factors for stroke and HF in AF patients have been defined through the development of prognostic models, but these models were developed specifically for each condition so it is unclear whether these prognostic factors are associated with increased risk of a particular condition, or simply any major adverse cardiovascular event. Additionally, some potentially important prognostic factors were not evaluated in these studies (e.g. anaemia and kidney failure).

Thus we chose to conduct an exploratory study of prognostic factors for HF, MI, and stroke in patients diagnosed with AF. We selected our candidate factors from those that have previously been associated with stroke, HF, or MI (in AF patients or the general population). Identification of prognostic factors for stroke, HF, and MI in those diagnosed with AF is a first step toward understanding both the development of these conditions, and the scope for targeting preventive treatments to improve prognosis.

This study will be undertaken using linked electronic health record data for primary and secondary care from CALIBER. This data set contains a broad range of clinically relevant, clinically conducted measurements of potential prognostic factors, and also provides a very large baseline sample from which we can draw a sufficient number of incident AF cases to investigate our three endpoints.

The study has two aims. First, to determine the cumulative incidence of fatal and non-fatal heart failure (HF), myocardial infarction (MI) and stroke (ischaemic, haemorrhagic, and NOS) in patients diagnosed with atrial fibrillation (AF). Differences between clinically relevant groups (e.g. men and women) will be explored. Second, to compare the direction and magnitude of associations between prognostic factors and the development of these conditions (HF, stroke, MI) in patients with AF. The following panels of prognostic factors will be investigated: sociodemographic; anthropomorphic and haemodynamic; behavioural; co-existing conditions (cardiovascular and non-cardiovascular); blood biomarkers; secondary preventive drugs.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults aged 30 years and over, registered with a CPRD practice that is up-to-standard, and having a minimum of one year of validated follow-up data. The index date is 1st January 1998 with follow-up ending on 26th March 2010, which corresponds to the administrative censoring date of the CPRD component of the CALIBER dataset.

Criteria

Inclusion Criteria:

  • Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record.
  • Patients in GPRD practices which are deemed "up to standard" by GPRD criteria
  • Patients whose records are deemed "acceptable" by GPRD criteria and contain at least one year of data
  • Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES.

Exclusion Criteria:

  • A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944397

Locations
United Kingdom
University College London
London, United Kingdom, WC1E 7H
Sponsors and Collaborators
University College, London
London School of Hygiene and Tropical Medicine
St Bartholomews and The Royal London Hospital
Investigators
Study Director: Harry Hemingway, FRCP University College, London
Principal Investigator: Katherine I Morley, PhD University College, London
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01944397     History of Changes
Other Study ID Numbers: CALIBER-12-03-PROG-18, 086091/Z/08/Z, RP-PG-0407-10314, G0902393
Study First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United Kingdom: CALIBER Scientific Oversight Committee

Keywords provided by University College, London:
Atrial fibrillation
Heart failure
Stroke
Myocardial infarction

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebral Infarction
Stroke
Heart Failure
Infarction
Myocardial Infarction
Arrhythmias, Cardiac
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014