The Risk of Myocardial Infarction in Users of Antipsychotic Agents

November 5, 2010 updated by: London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

90000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 7HT
        • London School of Hygiene and Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients will be excluded after experiencing their first MI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

University College, London

Investigators

  • Principal Investigator: Ruth Brauer, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 7, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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