Myocardial InfarctionNCT01569139
Comparison of Information Recorded in MINAP, GPRD and HES: a CALIBER Study
An observational study of Myocardial Infarction, run by London School of Hygiene and Tropical Medicine at 3 sites in United Kingdom.
Trial summary
Medical information is increasingly processed electronically. This study will describe the similarities and differences in the data recorded by different databases of electronic healthcare database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 21,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2011to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is comprised of "acceptable" patients registered at those GPRD practices that agreed to the linkage with MINAP and HES, whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population.
Who may be able to join
- Aged 18+
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria
- Patients in GPRD whose practice agreed to be linked to the MINAP and HES datasets.
- Patients whose records are deemed "acceptable" by GPRD criteria
- Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES and MINAP.
- Patients with evidence of myocardial infarction in one of the datasets (HES, MINAP, GPRD, ONS) between 1st January 2003 and 6th August 2009.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
London School of Hygiene and Tropical Medicine
London, WC1E 7HT
General Practice Research Database
London
University College, London
London
About this study
Official title: Comparison of the Information Recorded in the Myocardial Ischaemia National Audit Project, the General Practice Research Database and Hospital Episode Statistics: a CALIBER Study
Medical information is increasingly processed electronically. This study will describe the similarities and differences in the data recorded by different databases of electronic healthcare database. These will include the General Practice Research Database (GPRD) and the Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics (HES).
Read the detailed description
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 (GPRD) 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).
Specific aims are as follows:
- To validate the linkage between the three databases (General Practice Research Database (GPRD), Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES)) (checking age, sex and unique identifiers across databases) and establish a cohort of patients with acceptable registration status for further analysis.
- To describe the ways that MIs are recorded between the three datasets based on the 'best case definition' in each database.
- Starting from a 'best case definition' MINAP MI definition (based on the CALIBER phenotype algorithm, which itself is based on the international definition of MI), to examine the way in which the MINAP MI is recorded in GPRD and HES. This analysis will examine STEMI and NSTEMI separately.
- Starting from a 'best case definition' algorithm for MI in GPRD (to be decided by GPRD/LSHTM/UCL), to examine the ways in which this MI is recorded in MINAP and HES.
- Starting from a 'best case definition' choice of ICD-10 codes for MI in HES, to examine the ways in which this MI is recorded in MINAP and GPRD.
- To examine predictors of non-concordance between the three datasets.
- To develop recommendations for a new gold standard definition of MI in each of the databases, based on aims 1-3.
A detailed protocol for this study is available on request. This study has been approved by the Independent Scientific Advisory Committee (ISAC) and by the MINAP Academic Group (MAG).
Study investigators:
- Boggon, GPRD; Dr S. Denaxas, UCL; Professor H. Hemingway, UCL; E. Herrett, LSHTM; Dr A. Shah, UCL; Professor A. Timmis; Professor T. van Staa, GPRD.
- Conditions
- Myocardial Infarction
- Keywords
- Validation, Concordance, Myocardial infarction, Myocardial Ischaemia National Audit Project, General Practice Research Database, Hospital Episode Statistics, ONS mortality
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GPRD MI | Myocardial infarction, as identified in the GPRD data. | |
| MINAP MI | Myocardial infarction, as identified in MINAP data. | |
| HES MI | Myocardial infarction, as identified in HES data. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 21,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, General Practice Research Database
- Responsible party
- Principal investigator, Emily Herrett, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569139
- Sponsor's protocol ID
- Validation of CALIBER linkage
- Other IDs
- 086091/Z/08/Z
- Status last verified
- Oct 2015
- First submitted
- 30 Mar 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herrett E, Shah AD, Boggon R, Denaxas S, Smeeth L, van Staa T, Timmis A, Hemingway H. Completeness and diagnostic validity of recording acute myocardial infarction events in primary care, hospital care, disease registry, and national mortality records: cohort study. BMJ. 2013 May 20;346:f2350. doi: 10.1136/bmj.f2350.
PubMed 23692896
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Information Recorded in the Myocardial Ischaemia National Audit Project, the General Practice Research Database and Hospital Episode Statistics: a CALIBER Study
- ClinicalTrials.gov ID
- NCT01569139
- Acronym / sponsor ID
- Validation of CALIBER linkage
- Conditions
- Myocardial Infarction
- Keywords
- Validation, Concordance, Myocardial infarction, Myocardial Ischaemia National Audit Project, General Practice Research Database, Hospital Episode Statistics, ONS mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University College, London, General Practice Research Database
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2012 (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.
Medical information is increasingly processed electronically. This study will describe the similarities and differences in the data recorded by different databases of electronic healthcare database. These will include the General Practice Research Database (GPRD) and the Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics (HES).
Detailed description
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 (GPRD) 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).
Specific aims are as follows:
- To validate the linkage between the three databases (General Practice Research Database (GPRD), Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES)) (checking age, sex and unique identifiers across databases) and establish a cohort of patients with acceptable registration status for further analysis.
- To describe the ways that MIs are recorded between the three datasets based on the 'best case definition' in each database.
- Starting from a 'best case definition' MINAP MI definition (based on the CALIBER phenotype algorithm, which itself is based on the international definition of MI), to examine the way in which the MINAP MI is recorded in GPRD and HES. This analysis will examine STEMI and NSTEMI separately.
- Starting from a 'best case definition' algorithm for MI in GPRD (to be decided by GPRD/LSHTM/UCL), to examine the ways in which this MI is recorded in MINAP and HES.
- Starting from a 'best case definition' choice of ICD-10 codes for MI in HES, to examine the ways in which this MI is recorded in MINAP and GPRD.
- To examine predictors of non-concordance between the three datasets.
- To develop recommendations for a new gold standard definition of MI in each of the databases, based on aims 1-3.
A detailed protocol for this study is available on request. This study has been approved by the Independent Scientific Advisory Committee (ISAC) and by the MINAP Academic Group (MAG).
Study investigators:
- Boggon, GPRD; Dr S. Denaxas, UCL; Professor H. Hemingway, UCL; E. Herrett, LSHTM; Dr A. Shah, UCL; Professor A. Timmis; Professor T. van Staa, GPRD.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GPRD MI | – | –Myocardial infarction, as identified in the GPRD data. |
| MINAP MI | – | –Myocardial infarction, as identified in MINAP data. |
| HES MI | – | –Myocardial infarction, as identified in HES data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of "acceptable" patients registered at those GPRD practices that agreed to the linkage with MINAP and HES, whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population.
Key inclusion criteria (6 listed)
- Aged 18+
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria
- Patients in GPRD whose practice agreed to be linked to the MINAP and HES datasets.
- Patients whose records are deemed "acceptable" by GPRD criteria
- Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES and MINAP.
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Derived from this study: PubMed 23692896Herrett E, Shah AD, Boggon R, Denaxas S, Smeeth L, van Staa T, Timmis A, Hemingway H. Completeness and diagnostic validity of recording acute myocardial infarction events in primary care, hospital care, disease registry, and national mortality records: cohort study. BMJ. 2013 May 20;346:f2350. doi: 10.1136/bmj.f2350.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by London School of Hygiene and Tropical Medicine at 3 sites 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 6 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: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569139, which also lists 1 linked publication.
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 2 Oct 2015.