RecruitingNCT05326828

Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

60 participants

Start Date

May 24, 2022

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation MINOCA

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria13

≥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
≥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 Criteria14

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
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)

Interventions

DEVICECONFIRM Rx implantable cardiac rhythm monitor (Abbott)

Implantation of CONFIRM Rx ICM

DIAGNOSTIC_TESTSystematic etiologic work-up for underlying causes of MINOCA

Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)