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OpenTrials
Completed

NCT Number: NCT01379131

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients will be excluded if they do not fulfil one of the inclusion criteria.

Treatment and study plan

Primary outcomes

  1. First myocardial infarction (MI)

    Time frame: Average time frame: up to 20 years

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Registry information

Official study title

MI as the First Manifestation of Coronary Heart Disease: Distribution of Previous Cardiovascular Disease, Cardiovascular Risk Factors and Chest Pain in First MI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2011
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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