Myocardial InfarctionNCT01168869
Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction
An observational study of Myocardial Infarction, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial summary
Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease. These are termed 'unheralded' events as they have not been preceded by other forms of coronary artery disease. Unheralded MIs are important because of the high likelihood of missed opportunities for prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 9,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Dec 2013
- 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 patients registered at those GPRD practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all 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
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the MINAP dataset.
- Age over 18.
Who cannot join
- Patients will be excluded after experiencing their first MI.
- Patients will be excluded if they do not fulfil one of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, WC1E 7HT
About this study
Official title: Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction. A CALIBER Study
Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease. These are termed 'unheralded' events as they have not been preceded by other forms of coronary artery disease. Unheralded MIs are important because of the high likelihood of missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown.
This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those with angina of recent onset (MIs with premonitory symptoms).
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).
Using data from MINAP and GPRD, patients experiencing their first myocardial infarction (MI) will be separated into three categories:
- 'Heralded MI': patients who have been diagnosed or treated for cardiovascular disease for more than 90 days before MI.
- 'MI with premonitory symptoms': patients who have been diagnosed or treated for cardiovascular disease within the 90 days prior to MI.
- 'Unheralded MI': patients without a cardiovascular disease diagnosis or treatment at any time before MI.
Patients with MI will be identified in the linked GPRD-MINAP record. Using GPRD population denominators, this study will establish the absolute incidence rates of first 'unheralded' MI by calendar year, age, sex, season, MI subtype (ST-elevation MI and non ST-elevation MI) and region and compare these to the rates of first 'heralded' MIs and first 'MI with premonitory symptoms'.
- Conditions
- Myocardial Infarction
- Keywords
- Manifestation, Coronary Heart Disease, Myocardial infarction, Angina pectoris, Unheralded, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- Medical subject headings
- Myocardial Infarction, Coronary Disease, Angina Pectoris
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 patients | All patients included in "up to standard" GPRD practices that agreed to the linkage with the MINAP database are included in this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First myocardial infarction (MI)
First MIs will be divided into three groups:
(i) Those with previous manifestations of cardiovascular disease, diagnosed or treated more than 90 days before the MI. These are the 'Heralded MIs'.
(ii) Those with a diagnosis or treatment of cardiovascular disease occurring only within 90 days before MI. These are the 'MIs with premonitory symptoms'.
(iii) Those without any previous manifestation of cardiovascular disease at any time before MI. These are the 'Unheralded MIs'.
Measured: Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- British Medical Research Council, University College, London
- Responsible party
- Principal investigator, Emily Herrett, London School of Hygiene and Tropical Medicine
- Investigators
- Emily Herrett, MSc, Principal investigator, London School of Hygiene and Tropical MedicineHarry Hemingway, FRCP, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168869
- Sponsor's protocol ID
- CALIBER 09-07
- Other IDs
- 086091/Z/08/Z
- Status last verified
- Oct 2015
- First submitted
- 19 Jul 2010
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction. A CALIBER Study
- ClinicalTrials.gov ID
- NCT01168869
- Acronym / sponsor ID
- CALIBER 09-07
- Conditions
- Myocardial Infarction
- Keywords
- Manifestation, Coronary Heart Disease, Myocardial infarction, Angina pectoris, Unheralded, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- British Medical Research Council, University College, London
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Jul 2010 (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.
Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease. These are termed 'unheralded' events as they have not been preceded by other forms of coronary artery disease. Unheralded MIs are important because of the high likelihood of missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown.
This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those with angina of recent onset (MIs with premonitory symptoms).
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).
Using data from MINAP and GPRD, patients experiencing their first myocardial infarction (MI) will be separated into three categories:
- 'Heralded MI': patients who have been diagnosed or treated for cardiovascular disease for more than 90 days before MI.
- 'MI with premonitory symptoms': patients who have been diagnosed or treated for cardiovascular disease within the 90 days prior to MI.
- 'Unheralded MI': patients without a cardiovascular disease diagnosis or treatment at any time before MI.
Patients with MI will be identified in the linked GPRD-MINAP record. Using GPRD population denominators, this study will establish the absolute incidence rates of first 'unheralded' MI by calendar year, age, sex, season, MI subtype (ST-elevation MI and non ST-elevation MI) and region and compare these to the rates of first 'heralded' MIs and first 'MI with premonitory symptoms'.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPRD patients | – | –All patients included in "up to standard" GPRD practices that agreed to the linkage with the MINAP database are included in this cohort. |
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 patients registered at those GPRD practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all 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 (2 listed)
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the MINAP dataset.
- Age over 18.
Key exclusion criteria (2 listed)
- Patients will be excluded after experiencing their first MI.
- Patients will be excluded if they do not fulfil one of the inclusion criteria.
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
First myocardial infarction (MI)
Time frame: Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first.
First MIs will be divided into three groups: (i) Those with previous manifestations of cardiovascular disease, diagnosed or treated more than 90 days before the MI. These are the 'Heralded MIs'. (ii) Those with a diagnosis or treatment of cardiovascular disease occurring only within 90 days before MI. These are the 'MIs with premonitory symptoms'. (iii) Those without any previous manifestation of cardiovascular disease at any time before MI. These are the 'Unheralded MIs'.
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.
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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.
Emily Herrett, MSc principal investigator
London School of Hygiene and Tropical Medicine
Harry Hemingway, FRCP study director
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 Myocardial Infarction, run by London School of Hygiene and Tropical Medicine 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 2 inclusion and 2 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 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?
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.
What does the primary outcome measure?
First myocardial infarction (MI) (time frame: Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first.). 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 2 Oct 2015.