- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01944397
A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation
Risk Factors for the Development of Stroke, Heart Failure, and Myocardial Infarction in Patients Diagnosed With Atrial Fibrillation: a CALIBER Study
Study Overview
Status
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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London, United Kingdom, WC1E 7H
- University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Atrial fibrillation
Patients with a diagnosis of atrial fibrillation recorded in primary or secondary care during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Heart failure
Time Frame: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Myocardial infarction
Time Frame: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Stroke (ischaemic, haemorrhagic, and NOS)
Time Frame: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-cardiovascular mortality
Time Frame: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Cardiovascular mortality
Time Frame: Throughout follow-up (maximum 12 years)
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Excluding heart failure, myocardial infarction, stroke
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Throughout follow-up (maximum 12 years)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine I Morley, PhD, University College, London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arrhythmias, Cardiac
- Myocardial Infarction
- Infarction
- Heart Failure
- Stroke
- Atrial Fibrillation
Other Study ID Numbers
- CALIBER-12-03-PROG-18
- RP-PG-0407-10314 (Other Grant/Funding Number: Wellcome Trust)
- 086091/Z/08/Z (Other Grant/Funding Number: Wellcome Trust)
- G0902393 (Other Grant/Funding Number: Medical Research Council (UK))
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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