Trials / Completed
CompletedNCT01168869
Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction
Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction. A CALIBER Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 9,000 (actual)
- Sponsor
- London School of Hygiene and Tropical Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2010-07-23
- Last updated
- 2015-10-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01168869. Inclusion in this directory is not an endorsement.