Heart FailureiHFNCT02384213
Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction: a CALIBER Study
An observational study of Heart Failure and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Myocardial Infarction
- How many people
- 55,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- A past medical history of heart failure before index MI.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Farr Institute, University College London
London, NW1 2DA
About this study
Official title: Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction (iHF): a CALIBER Study
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.
Read the 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).
- Conditions
- Heart Failure, Myocardial Infarction
- Medical subject headings
- Heart Failure, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure
Measured: Throughout follow-up (maximum 12 years)
Secondary outcomes (3)
Non-cardiovascular mortality
Measured: Throughout follow-up (maximum 12 years)
Cardiovascular mortality
Measured: Throughout follow-up (maximum 12 years)
Myocardial infarction
Measured: Throughout follow-up (maximum 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Harry Hemingway, FRCP, Study director, University College, LondonFolkert W. Asselbergs, MD, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384213
- Sponsor's protocol ID
- 14_198R
- Acronym
- iHF
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction (iHF): a CALIBER Study
- ClinicalTrials.gov ID
- NCT02384213
- Acronym / sponsor ID
- iHF / 14_198R
- Conditions
- Heart Failure, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- A past medical history of heart failure before index MI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart failure
Time frame: Throughout follow-up (maximum 12 years)
3 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Hemingway, FRCP study director
University College, London
Folkert W. Asselbergs, MD, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure (time frame: Throughout follow-up (maximum 12 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.