A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01944397|
Recruitment Status : Unknown
Verified September 2013 by University College, London.
Recruitment status was: Active, not recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
|Condition or disease|
|Atrial Fibrillation Heart Failure Stroke Myocardial Infarction|
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).
|Study Type :||Observational|
|Estimated Enrollment :||125000 participants|
|Official Title:||Risk Factors for the Development of Stroke, Heart Failure, and Myocardial Infarction in Patients Diagnosed With Atrial Fibrillation: a CALIBER Study|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
Patients with a diagnosis of atrial fibrillation recorded in primary or secondary care during the study period.
- Stroke (ischaemic, haemorrhagic, and NOS) [ Time Frame: Throughout follow-up (maximum 12 years) ]
- Myocardial infarction [ Time Frame: Throughout follow-up (maximum 12 years) ]
- Heart failure [ Time Frame: Throughout follow-up (maximum 12 years) ]
- Non-cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]
- Cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]Excluding heart failure, myocardial infarction, stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944397
|University College London|
|London, United Kingdom, WC1E 7H|
|Study Director:||Harry Hemingway, FRCP||University College, London|
|Principal Investigator:||Katherine I Morley, PhD||University College, London|