Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction: a CALIBER Study

NCT02384213 | Unknown DMC

• 1 other identifier: 14_198R
• Study Type: observational
• Target: 55,000
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this study are: i) to investigate the incidence and prevalence of fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its evolution over time in men and in women; ii) to identify prognostic factors for developing HF in patients who had an MI.

Conditions

Heart Failure; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Heart failure

  Throughout follow-up (maximum 12 years)

Secondary Outcomes (3)

• Non-cardiovascular mortality

  Throughout follow-up (maximum 12 years)

• Cardiovascular mortality

  Throughout follow-up (maximum 12 years)

• Myocardial infarction

  Throughout follow-up (maximum 12 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults aged 18 years and over, registered in CPRD practices in England consenting to data linkage, with at least one year of validated pre-study follow-up data, and who experienced a first MI recorded in CALIBER from 1998 to 2010 are potentially eligible. Definition MI: MI as recorded in HES or ONS (ICD-10 codes I21-I23), CPRD or MINAP. The type of MI (ST-elevation MI, STEMI; non ST-elevation MI, NSTEMI; or MI not otherwise specified) is coded in MINAP and CPRD. Patients will be right censored at end-of-study, which corresponds to the administrative censoring date of the CPRD dataset, patient death or patient deregistration from the general practice.

You may qualify if:

• Patients with a coded diagnosis for myocardial infarction in their primary or secondary care record.
• Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria.
• Patients with at least one year of follow-up in the CPRD practice CPRD.

You may not qualify if:

• A past medical history of heart failure before index MI.

Sponsors & Collaborators

• University College, London: lead
• UMC Utrecht: collaborator

Study Sites (1)

Farr Institute, University College London

London, NW1 2DA, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

• Folkert W. Asselbergs, MD, 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: March 4, 2015
• First Posted: March 10, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

GB (1)