Myocardial InfarctionNCT01236274
The Risk of Myocardial Infarction in Users of Antipsychotic Agents
An observational study of Myocardial Infarction, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial summary
A number of studies have suggested an association between the use of antipsychotic agents and cardiovascular mortality. However, the relationship between cardiac events and the use of antipsychotic drugs is not clear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 90,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to 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 patients registered at those GPRD practices that agreed to linkage with the MINAP database, and whose practices are "up to standard" according to the GPRD criteria. Self-controlled Case Series: Patients who experienced an MI and received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD, will be included and will act as their own control. Case- control Study: All cases of first recorded occurrence of an MI, identified by the recording of a Read code in the GPRD within the UTS period until December 2009 will be identified. Five controls for each case will be selected matched by age, gender, General Practitioner and registration in the GPRD on the date of MI of the case.
Who may be able to join
- Patients in GPRD practices that agreed to linkage with the MINAP database
- Age over 18
- Self-controlled case-series: patients who received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD
- Self-controlled case-series: patients who experienced a first record of MI at least 12 months after the start of UTS follow-up period in the GPRD data record
Who cannot join
- Patients will be excluded after experiencing their first MI
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: The Risk of Myocardial Infarction in Users of Antipsychotic Agents: a CALIBER Study
A number of studies have suggested an association between the use of antipsychotic agents and cardiovascular mortality. However, the relationship between cardiac events and the use of antipsychotic drugs is not clear. Patients experiencing psychoses and in need for antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of antipsychotic medication. Two studies have specifically investigated the association between the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as an outcome measure, reporting no association and a positive association respectively. This difference in results may be explained by the use of different measures as well as study designs in both studies and because of different limitations with regard to controlling for lifestyle and medical risk factors. This study aims to assess the relationship between the risk of MI and recent exposure to antipsychotic agents by using the self-controlled case series method with which we are able to control for fixed confounders. The results of the self-controlled case series method will be compared to the results of a case-control study using the same data to compare the estimates of both methods.
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).
The use of antipsychotics is associated with a rise in cardiovascular events. Previous studies investigating the effect of antipsychotic agents on the risk of Myocardial Infarction (MI) led to conflicting results with reports of either no association or a positive association. As patient populations for whom antipsychotic agents are indicated differ considerably from healthy comparison populations, confounding by indication could be substantial. Whilst confounding can be accounted for if known and measured, residual confounding remains a potential problem. This study aims to assess the relationship between the risk of MI and recent exposure to antipsychotic agents by using the self-controlled case series method with which we are able to control for fixed confounders. The results of the self-controlled case series method will be compared to the results of a case-control study using the same data to explore the role of confounding by indication.
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Antipsychotic agents, Self-controlled case series method, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- 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 |
|---|---|---|
| Antipsychotic agents AND MI | In the self-controlled case series study, patients who experienced a myocardial infarction and received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD will be included and will act as their own control. | |
| Myocardial Infarction | In the case-control study, all cases with a first recorded occurrence of MI during up to standard (UTS) follow-up in the GPRD will be identified | |
| No Myocardial Infarction | In the case-control study, a control group with subjects who never experienced a myocardial infarction will be matched to cases (5:1) by age, gender, General Practitioner and registration in the GPRD on the date of MI of the case |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of a myocardial infarction recorded in the patient's medical record
Measured: Patients in the General Practice Research database (GPRD) are followed from registration until they leave the practice, die, or 31st of 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 posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
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
- 90,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Investigators
- Ruth Brauer, Principal investigator, London School of Hygiene and Tropical MedicineHarry Hemingway, FRCP, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236274
- Sponsor's protocol ID
- 10-01
- Status last verified
- Nov 2010
- First submitted
- 5 Nov 2010
- Last updated
- 8 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Myocardial Infarction in Users of Antipsychotic Agents: a CALIBER Study
- ClinicalTrials.gov ID
- NCT01236274
- Acronym / sponsor ID
- 10-01
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Antipsychotic agents, Self-controlled case series method, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Nov 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.
A number of studies have suggested an association between the use of antipsychotic agents and cardiovascular mortality. However, the relationship between cardiac events and the use of antipsychotic drugs is not clear. Patients experiencing psychoses and in need for antipsychotic agents may be at a higher risk of cardiac events regardless of any effect of antipsychotic medication. Two studies have specifically investigated the association between the use of antipsychotics and the risk of cardiac events using Myocardial Infarction (MI) as an outcome measure, reporting no association and a positive association respectively. This difference in results may be explained by the use of different measures as well as study designs in both studies and because of different limitations with regard to controlling for lifestyle and medical risk factors. This study aims to assess the relationship between the risk of MI and recent exposure to antipsychotic agents by using the self-controlled case series method with which we are able to control for fixed confounders. The results of the self-controlled case series method will be compared to the results of a case-control study using the same data to compare the estimates of both methods.
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).
The use of antipsychotics is associated with a rise in cardiovascular events. Previous studies investigating the effect of antipsychotic agents on the risk of Myocardial Infarction (MI) led to conflicting results with reports of either no association or a positive association. As patient populations for whom antipsychotic agents are indicated differ considerably from healthy comparison populations, confounding by indication could be substantial. Whilst confounding can be accounted for if known and measured, residual confounding remains a potential problem. This study aims to assess the relationship between the risk of MI and recent exposure to antipsychotic agents by using the self-controlled case series method with which we are able to control for fixed confounders. The results of the self-controlled case series method will be compared to the results of a case-control study using the same data to explore the role of confounding by indication.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic agents AND MI | – | –In the self-controlled case series study, patients who experienced a myocardial infarction and received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD will be included and will act as their own control. |
| Myocardial Infarction | – | –In the case-control study, all cases with a first recorded occurrence of MI during up to standard (UTS) follow-up in the GPRD will be identified |
| No Myocardial Infarction | – | –In the case-control study, a control group with subjects who never experienced a myocardial infarction will be matched to cases (5:1) by age, gender, General Practitioner and registration in the GPRD on the date of MI of the case |
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 linkage with the MINAP database, and whose practices are "up to standard" according to the GPRD criteria. Self-controlled Case Series: Patients who experienced an MI and received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD, will be included and will act as their own control. Case- control Study: All cases of first recorded occurrence of an MI, identified by the recording of a Read code in the GPRD within the UTS period until December 2009 will be identified. Five controls for each case will be selected matched by age, gender, General Practitioner and registration in the GPRD on the date of MI of the case.
Key inclusion criteria (4 listed)
- Patients in GPRD practices that agreed to linkage with the MINAP database
- Age over 18
- Self-controlled case-series: patients who received an antipsychotic agent during up to standard (UTS) follow-up in the GPRD
- Self-controlled case-series: patients who experienced a first record of MI at least 12 months after the start of UTS follow-up period in the GPRD data record
Key exclusion criteria (1 listed)
- Patients will be excluded after experiencing their first 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
First occurrence of a myocardial infarction recorded in the patient's medical record
Time frame: Patients in the General Practice Research database (GPRD) are followed from registration until they leave the practice, die, or 31st of December 2009, whichever occurs first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2010.
- Related InfoLink provided by the sponsor.
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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.
Ruth Brauer 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 4 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 8 Nov 2010. 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?
First occurrence of a myocardial infarction recorded in the patient's medical record (time frame: Patients in the General Practice Research database (GPRD) are followed from registration until they leave the practice, die, or 31st of 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 8 Nov 2010.