Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction

NCT ID: NCT01168869

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-12-31

Brief 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. 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'.

Conditions

Myocardial Infarction

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients will be excluded after experiencing their first MI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Emily Herrett

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Herrett, MSc

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Harry Hemingway, FRCP

Role: STUDY_DIRECTOR

University College, London

Locations

London School of Hygiene and Tropical Medicine

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

086091/Z/08/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIBER 09-07

Identifier Type: -

Identifier Source: org_study_id