Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
Known atrial fibrillation or atrial flutter
History of atrial fibrillation or atrial flutter ablation
Known coronary artery disease
Previous MI
Trial population
Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CONFIRM Rx implantable cardiac rhythm monitor (Abbott)
DeviceImplantation of CONFIRM Rx ICM
Systematic etiologic work-up for underlying causes of MINOCA
Diagnostic testIntracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ICM group2 interventions
Group B: Non-ICM group1 intervention
Trial outcomes
Primary outcomes
1
ICM group: Atrial fibrillation
The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM
Time frame
1 year2
Non-ICM group: Frequency of underlying causes of MINOCA
The frequency of underlying causes of MINOCA (i.e. plaque rupture, plaque erosion, coronary thrombus, coronary dissection, eruptive calcific nodule, coronary spasm (including microvascular dysfunction), coronary thromboembolism due to intra- or extracardiac sources of thrombi (including thromboembolism in the context of a persistent foramen ovale (PFO)), atrial fibrillation according to 3 7-day-Holter-ECGs, other sources of coronary embolism (e.g. vegetations, complex aortic plaques), and arterial thrombophilia
Time frame
1 yearSecondary outcomes
1
ICM group: Time to first diagnosed atrial fibrillation
Time to first occurrence of atrial fibrillation according to ICM
Time frame
~2 years (battery end of life or explantation of ICM)2
ICM group: Time to different durations of first diagnosed atrial fibrillation
Time to first diagnosis of atrial fibrillation (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour)
Time frame
~2 years (battery end of life or explantation of ICM)3
ICM group: Atrial fibrillation burden
Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)
Time frame
~2 years (battery end of life or explantation of ICM)4
ICM group: First diagnosis of atrial fibrillation, stroke or death
Time to composite of first diagnosis of atrial fibrillation, stroke or death
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
University Hospital, Zürich
Collaborator
Bangerter-Rhyner Stiftung
Collaborator
Abbott
Collaborator
Source ClinicalTrials.gov