Status:
RECRUITING
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University Hospital, Zürich
Bangerter-Rhyner Stiftung
Conditions:
MINOCA
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Brief 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 myocar...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 15 2031
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05326828
Start Date
May 24 2022
End Date
May 15 2031
Last Update
October 30 2024
Active Locations (2)
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1
Bern University Hospital Inselspital
Bern, Switzerland, 3010
2
University Hospital Zurich USZ
Zurich, Switzerland, 8091