Clinical trial NCT05326828: Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Official title: Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MINOCA
Atrial Fibrillation
Keywords: Implantable cardiac monitor
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: Bangerter-Rhyner Stiftung
name: Abbott
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland

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.

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 50% of these patients remain without appropriate diagnosis and treatment. A multidisciplinary etiologic work-up of MINOCA has recently been proposed by international consensus documents. The present study aims for a structured scientific data collection from a full guideline-based work-up after MINOCA and follow-up of 5 years to assess clinical outcomes.

Untreated atrial fibrillation is a potentially neglected underlying cause of MINOCA. As implantable cardiac monitors (ICM) can detect atrial fibrillation with high accuracy, the aim of this study is, for the first time, to assess the occurrence of first diagnosed atrial fibrillation with the use of ICM in patients with MINOCA.

To allow for an all-comers data collection, patients with contraindication(s) to ICM implantation will be enrolled into the non-ICM group to assess the frequency of underlying causes of MINOCA and clinical outcomes throughout 5 years.

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)

Primary outcomes:
measure: ICM group: Atrial fibrillation
timeFrame: 1 year
measure: Non-ICM group: Frequency of underlying causes of MINOCA
timeFrame: 1 year
Secondary outcomes:
measure: ICM group: Time to first diagnosed atrial fibrillation
timeFrame: ~2 years (battery end of life or explantation of ICM)
measure: ICM group: Time to different durations of first diagnosed atrial fibrillation
timeFrame: ~2 years (battery end of life or explantation of ICM)
measure: ICM group: Atrial fibrillation burden
timeFrame: ~2 years (battery end of life or explantation of ICM)
measure: ICM group: First diagnosis of atrial fibrillation, stroke or death
timeFrame: 1 year
measure: ICM group: Other brady- or tachyarrhythmias
timeFrame: ~2 years (battery end of life or explantation of ICM)
measure: ICM group: Predictive value of CMR parameters for atrial fibrillation
timeFrame: ~2 years (battery end of life or explantation of ICM)
measure: ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA
timeFrame: 1 year
measure: Both groups: Clinical outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital Inselspital
city: Zürich
country: Switzerland
facility: University Hospital Zurich USZ
Study officials:
affiliation: Bern University Hospital Inselspital
name: Lorenz Räber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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