- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01379131
Previous Cardiovascular Disease, Cardiovascular Risk Factors and Chest Pain in First Myocardial Infarction
MI as the First Manifestation of Coronary Heart Disease: Distribution of Previous Cardiovascular Disease, Cardiovascular Risk Factors and Chest Pain in First MI
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Patients GPRD
Tous les patients inclus dans les pratiques GPRD "aux normes" qui ont accepté le lien avec la base de données MINAP sont inclus dans cette cohorte.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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First myocardial infarction (MI)
Délai: Average time frame: up to 20 years
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Average time frame: up to 20 years
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CALIBER 09-07b
- 086091/Z/08/Z (Autre subvention/numéro de financement: Wellcome Trust)
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