The Risk of Myocardial Infarction in Users of Antipsychotic Agents

NCT01236274 | Unknown DMC

• 1 other identifier: 10-01
• Study Type: observational
• Target: 90,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Antipsychotic agents; Self-controlled case series method; General Practice Research Database; Myocardial Ischaemia National Audit Project; CALIBER

Outcome Measures

Primary Outcomes (1)

• First occurrence of a myocardial infarction recorded in the patient's medical record

  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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients will be excluded after experiencing their first MI

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University College, London: collaborator

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ruth Brauer

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 8, 2010

Record last verified: 2010-11

Locations

GB (1)