MINOCAImplantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMINOCA+10
+ Arythmies cardiaques
+ Fibrillation Auriculaire
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 24 mai 2022
Date à laquelle le premier participant a commencé l'étude.Approximately 5-6% of patients with acute myocardial infarction (AMI) have myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.<50% stenoses) on coronary angiography and up to 50% of these patients remain without appropriate diagnosis and treatment. A multidisciplinary etiologic work-up of MINOCA has recently been proposed by international consensus documents. The present study aims for a structured scientific data collection from a full guideline-based work-up after MINOCA and follow-up of 5 years to assess clinical outcomes. Untreated atrial fibrillation is a potentially neglected underlying cause of MINOCA. As implantable cardiac monitors (ICM) can detect atrial fibrillation with high accuracy, the aim of this study is, for the first time, to assess the occurrence of first diagnosed atrial fibrillation with the use of ICM in patients with MINOCA. To allow for an all-comers data collection, patients with contraindication(s) to ICM implantation will be enrolled into the non-ICM group to assess the frequency of underlying causes of MINOCA and clinical outcomes throughout 5 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 85 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria ICM group 1. ≥18 years of age 2. Written informed consent 3. Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction 4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery 5. No clinically overt specific cause for the acute presentation 6. Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR) 7. No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation Exclusion Criteria ICM group: 1. Known atrial fibrillation or atrial flutter 2. History of atrial fibrillation or atrial flutter ablation 3. Known coronary artery disease 4. Previous MI 5. Previous percutaneous coronary intervention (PCI) 6. Previous coronary artery bypass grafting (CABG) 7. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) \<30 ml/min) 8. Contraindications to ICM implantation 9. Clear underlying cause of MINOCA before ICM implantation Inclusion Criteria non-ICM group: 1. ≥18 years of age 2. Written informed consent 3. AMI type 1 in accordance with the 4th universal definition of myocardial infarction 4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery 5. No clinically overt specific cause for the acute presentation 6. Subendocardial or transmural LGE consistent with an ischemic etiology on CMR Exclusion Criteria non-ICM group: 1. Known coronary artery disease 2. Previous MI 3. Previous PCI 4. Previous CABG 5. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR \<30 ml/min)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Bern University Hospital Inselspital
Bern, SwitzerlandOuvrir Bern University Hospital Inselspital dans Google MapsUniversity Hospital Zurich USZ
Zurich, Switzerland