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Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Recruitingn/aAges 18 Years - 85 YearsAllInsel Gruppe AG, University Hospital Bern
NCT05326828 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • CONFIRM Rx implantable cardiac rhythm monitor (Abbott)
  • Systematic etiologic work-up for underlying causes of MINOCA
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Where

2 sites
Bern University Hospital Inselspital
Bern, Switzerland
University Hospital Zurich USZ
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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