Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Insel Gruppe AG, University Hospital Bern60 enrolled

Overview

Myocardial infarction with non-obstructive coronary arteries (MINOCA) (i.e.\<50% stenoses) on coronary angiography) is an underappreciated clinical entity concerning 5-6% of patients with acute myocardial infarction. Approximately 50% of these patients remain without appropriate diagnosis and treatment. The MINOCA study aims at systematically assessing the frequency of underlying pathologies of MINOCA and outcomes with a multidisciplinary etiologic work-up and follow-up of 5 years including, for the first time, an implantable cardiac monitor (ICM) to assess the frequency of atrial fibrillation as underlying cause for MINOCA.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

MINOCA Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

ICM group: Atrial fibrillation

The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM

Time frame: 1 year

Non-ICM group: Frequency of underlying causes of MINOCA

The frequency of underlying causes of MINOCA (i.e. plaque rupture, plaque erosion, coronary thrombus, coronary dissection, eruptive calcific nodule, coronary spasm (including microvascular dysfunction), coronary thromboembolism due to intra- or extracardiac sources of thrombi (including thromboembolism in the context of a persistent foramen ovale (PFO)), atrial fibrillation according to 3 7-day-Holter-ECGs, other sources of coronary embolism (e.g. vegetations, complex aortic plaques), and arterial thrombophilia

Time frame: 1 year