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| Sponsor: | London School of Hygiene and Tropical Medicine |
|---|---|
| Collaborators: |
British Medical Research Council University College, London |
| Information provided by: | London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01168869 |
Purpose
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).
| Condition |
|---|
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Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction. A CALIBER Study |
First MIs will be divided into three groups:
(i) Those with previous manifestations of cardiovascular disease, diagnosed or treated more than 90 days before the MI. These are the 'Heralded MIs'.
(ii) Those with a diagnosis or treatment of cardiovascular disease occurring only within 90 days before MI. These are the 'MIs with premonitory symptoms'.
(iii) Those without any previous manifestation of cardiovascular disease at any time before MI. These are the 'Unheralded MIs'.
| Estimated Enrollment: | 2100000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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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:
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'.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population is comprised of patients registered at those GPRD practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| London School of Hygiene and Tropical Medicine | |
| London, United Kingdom, WC1E 7HT | |
| Principal Investigator: | Emily Herrett, MSc | London School of Hygiene and Tropical Medicine |
| Study Director: | Harry Hemingway, FRCP | University College, London |
More Information
| Responsible Party: | Miss Emily Herrett, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01168869 History of Changes |
| Other Study ID Numbers: | CALIBER 09-07, 086091/Z/08/Z |
| Study First Received: | July 19, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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Manifestation Coronary Heart Disease Myocardial infarction Angina pectoris |
Unheralded General Practice Research Database Myocardial Ischaemia National Audit Project CALIBER |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Infarction Myocardial Infarction Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis |