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Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

RECRUITINGSponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
SponsorInsel Gruppe AG, University Hospital Bern
Started2022-05-24
Est. completion2026-05-24
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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)

Conditions3

Atrial FibrillationHeart DiseaseMINOCA

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