Using an implantable cardiac monitor to find atrial fibrillation in patients with MINOCA
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
This study is testing whether an implantable heart monitor can help find atrial fibrillation in patients who have had a heart attack with non-blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Bern and 1 other locations) |
| Trial ID | NCT05326828 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who have experienced a myocardial infarction with non-obstructive coronary arteries (MINOCA), a condition that often goes undiagnosed. It aims to systematically assess the underlying causes of MINOCA and the frequency of atrial fibrillation using an implantable cardiac monitor (ICM). Patients will undergo a multidisciplinary work-up and be followed for five years to evaluate clinical outcomes. The study includes both patients who will receive the ICM and those who cannot due to contraindications, allowing for comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute myocardial infarction with non-obstructive coronary arteries and no clear underlying cause.
Not a fit: Patients with known atrial fibrillation or significant coronary artery disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment options for patients with MINOCA by identifying atrial fibrillation as a common underlying cause.
How similar studies have performed: While the use of implantable cardiac monitors is established, this specific approach to assess atrial fibrillation in MINOCA patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bern and 1 other locations
- Bern University Hospital Inselspital — Bern, Switzerland (Recruiting)
- University Hospital Zurich USZ — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lorenz Räber, MD, PhD — Bern University Hospital Inselspital
- Study coordinator: Lorenz Räber, MD, PhD
- Email: lorenz.raeber@insel.ch
- Phone: +41 31 632 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.