NCT05326828 Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
| NCT ID | NCT05326828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | MINOCA |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2026-05-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-05-24 with a primary completion date of 2026-05-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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)
Contact & Investigator
Lorenz Räber, MD, PhD
PRINCIPAL INVESTIGATOR
Bern University Hospital Inselspital
Frequently Asked Questions
Who can join the NCT05326828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying MINOCA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05326828 currently recruiting?
Yes, NCT05326828 is actively recruiting participants. Contact the research team at lorenz.raeber@insel.ch for enrollment information.
Where is the NCT05326828 trial being conducted?
This trial is being conducted at Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT05326828 clinical trial?
NCT05326828 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Lorenz Räber, MD, PhD at Bern University Hospital Inselspital. The trial plans to enroll 60 participants.