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

NCT01944397 | Unknown DMC

• 4 other identifiers: CALIBER-12-03-PROG-18086091/Z/08/ZRP-PG-0407-10314G0902393
• Study Type: observational
• Target: 125,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Heart Failure; Stroke; Myocardial Infarction

Keywords

Atrial fibrillation; Heart failure; Stroke; Myocardial infarction

Outcome Measures

Primary Outcomes (3)

• Stroke (ischaemic, haemorrhagic, and NOS)

  Throughout follow-up (maximum 12 years)

• Myocardial infarction

  Throughout follow-up (maximum 12 years)

• Heart failure

  Throughout follow-up (maximum 12 years)

Secondary Outcomes (2)

• Non-cardiovascular mortality

  Throughout follow-up (maximum 12 years)

• Cardiovascular mortality

  Throughout follow-up (maximum 12 years)

Study Arms (1)

Atrial fibrillation

Patients with a diagnosis of atrial fibrillation recorded in primary or secondary care during the study period.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation

Sponsors & Collaborators

• University College, London: lead
• London School of Hygiene and Tropical Medicine: collaborator
• St Bartholomews and The Royal London Hospital: collaborator

Study Sites (1)

University College London

London, WC1E 7H, United Kingdom

Location

Related Links

• CALIBER Data Portal (including additional study information)

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Stroke; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Myocardial Ischemia; Infarction; Ischemia; Necrosis

Study Officials

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

• Katherine I Morley, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

GB (1)