Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Recruiting · NCT05326828 · Observational (researchers observe without assigning treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- ICM group
- ≥18 years of age
- Written informed consent
- Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction
- Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
- No clinically overt specific cause for the acute presentation
- Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)
- No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation
Exclusion criteria
- ICM group:
- Known atrial fibrillation or atrial flutter
- History of atrial fibrillation or atrial flutter ablation
- Known coronary artery disease
- Previous MI
- Previous percutaneous coronary intervention (PCI)
- Previous coronary artery bypass grafting (CABG)
- Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) \<30 ml/min)
- Contraindications to ICM implantation
- Clear underlying cause of MINOCA before ICM implantation
- Inclusion Criteria non-ICM group:
- ≥18 years of age
- Written informed consent
- AMI type 1 in accordance with the 4th universal definition of myocardial infarction
- Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
- No clinically overt specific cause for the acute presentation
- Subendocardial or transmural LGE consistent with an ischemic etiology on CMR
- Exclusion Criteria non-ICM group:
- Known coronary artery disease
- Previous MI
- Previous PCI
- Previous CABG
- Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR \<30 ml/min)
Where it is running
2 locations listed.
- Bern University Hospital Inselspital - Bern, Switzerland
- University Hospital Zurich USZ - Zurich, Switzerland