Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

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.

Condition or disease
Heart Failure Myocardial Infarction

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).


Layout table for study information
Study Type : Observational
Estimated Enrollment : 55000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction (iHF): a CALIBER Study
Study Start Date : March 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Heart failure [ Time Frame: Throughout follow-up (maximum 12 years) ]

Secondary Outcome Measures :
  1. Non-cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]
  2. Cardiovascular mortality [ Time Frame: Throughout follow-up (maximum 12 years) ]
  3. Myocardial infarction [ Time Frame: Throughout follow-up (maximum 12 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

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): NCT02384213


Locations
Layout table for location information
United Kingdom
Farr Institute, University College London
London, United Kingdom, NW1 2DA
Sponsors and Collaborators
University College, London
UMC Utrecht
Investigators
Layout table for investigator information
Study Director: Harry Hemingway, FRCP University College, London
Principal Investigator: Folkert W. Asselbergs, MD, PhD University College, London

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02384213     History of Changes
Other Study ID Numbers: 14_198R
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases