Previous Cardiovascular Disease, Cardiovascular Risk Factors and Chest Pain in First Myocardial Infarction

NCT ID: NCT01379131

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 atherosclerotic disease. Such MIs are important because of the high likelihood of missed opportunities for prevention. A recent analysis using CALIBER data estimated this proportion at 60%.

Further to this research, another level of complexity can be added to improve our understanding of these MIs. This is the concept of a completely 'unanticipated' MI, which can be defined as: MI occurring as the first manifestation of atherosclerotic disease and without any traditional cardiovascular risk factors and without any prior chest pain. Such 'unanticipated' MIs cannot be foreseen by the medical profession and their frequency in the population is unknown.

Therefore the aim of this study is to describe the distribution of previously diagnosed cardiovascular disease, cardiovascular risk factors and chest pain in patients with first MI. This will provide an estimate of the number of 'unanticipated' MIs and of the levels of risk factors in unheralded, compared to heralded MI.

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 GPRD, MINAP, ONS mortality data and Hospital Episode Statistics (HES), this study will identify patients with a first MI (STEMI and non-STEMI). Information from in-patient hospital visits, general practice data and self-reported data in MINAP, this study will allow the quantification of the level and timing of cardiovascular disease before first MI. It will also measure the levels of cardiovascular risk factors and chest pain occurring before MI.

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

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 09-07b

Identifier Type: -

Identifier Source: org_study_id