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

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ClinicalTrials.gov Identifier: NCT02384213
Recruitment Status : Unknown
Verified March 2015 by University College, London.
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date March 4, 2015
First Posted Date March 10, 2015
Last Update Posted Date March 10, 2015
Study Start Date March 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2015)
Heart failure [ Time Frame: Throughout follow-up (maximum 12 years) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 4, 2015)
  • Non-cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]
  • Cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]
  • Myocardial infarction [ Time Frame: Throughout follow-up (maximum 12 years) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction: a CALIBER Study
Official Title Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction (iHF): a CALIBER Study
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.
Detailed Description

Heart failure (HF) is a major medical problem in the western world. Heart failure is associated with a substantial morbidity and mortality and contributes to a significant extent to economic loss for healthcare systems. An increased prevalence of HF is expected as survival is increasing after an ischaemic event due to primary percutaneous coronary intervention (PCI) and due to demographic changes (ageing population). At this moment, no contemporary data of large scale electronic health records cohorts have been reported regarding the incidence of HF following myocardial infarction (MI). The aim of this research is to investigate the incidence of HF following MI across different time periods and search for predictors of HF following MI to identify high-risk patients. Using CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) data, patients with HF following MI will be identified and the incidence of HF after MI will be described. Prognostic factors associated with the occurrence of HF in patients having experienced a MI will be studied. This is important for future observational research, clinical trials, measuring health outcomes and guideline development.

The study has two aims. First to describe the 'real-world' incidence of HF following MI. Differences between clinically relevant groups (e.g. men and women, and patients with or without - ST-elevation MI,) will be examined. Second, to identify prognostic factors for developing HF in patients who had an MI. The following panels of prognostic factors will be investigated: sociodemographic; anthropomorphic and haemodynamic; behavioural; co-existing conditions (cardiovascular and non-cardiovascular); blood biomarkers; prescribed secondary preventive medication.

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 (CPRD) 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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Heart Failure
  • Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 4, 2015)
55000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • A past medical history of heart failure before index MI.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02384213
Other Study ID Numbers 14_198R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators UMC Utrecht
Investigators
Study Director: Harry Hemingway, FRCP University College, London
Principal Investigator: Folkert W. Asselbergs, MD, PhD University College, London
PRS Account University College, London
Verification Date March 2015