An observational study in MINOCA and Atrial Fibrillation, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
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.
29 studies on the registry are indexed under MINOCA; 18 are open to participants now.
This study's planned enrollment of 60 is below the median of 500 across 20 observational studies indexed under MINOCA.
Browse MINOCA studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland
Inclusion Criteria ICM group
Exclusion Criteria ICM group:
Inclusion Criteria non-ICM group:
Exclusion Criteria non-ICM group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients eligible for ICM implantation for screening of atrial fibrillation
Device: CONFIRM Rx implantable cardiac rhythm monitor (Abbott) · Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA
Patients ineligible for ICM implantation due to 1) refusal, 2) contraindication, or 3) clear underlying cause of MINOCA before ICM implantation.
Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA
Implantation of CONFIRM Rx ICM
Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)
ICM group: Atrial fibrillation
The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM
Time frame: 1 year
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 year
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)
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)
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)
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 year
ICM group: Other brady- or tachyarrhythmias
The incidence and time to first occurrence of other brady- or tachyarrhythmias
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Predictive value of CMR parameters for atrial fibrillation
Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA
The frequency of non atrial fibrillation related etiologies of MINOCA (i.e. plaque rupture, plaque erosion, coronary thrombus, coronary dissection, eruptive calcific nodule, coronary spasm (including microvascular dysfunction), coronary thromboembolism due to other intra- or extracardiac sources of thrombi not related to atrial fibrillation (including thromboembolism in the context PFO), other sources of coronary embolism (e.g. vegetations, complex aortic plaques), and arterial thrombophilia
Time frame: 1 year
Both groups: Clinical outcomes
The occurrence of all-cause death, cardiac death, myocardial infarction, coronary revascularization, stroke, transitory ischemic attack, deep vein thrombosis, pulmonary embolism, and systemic arterial thromboembolism
Time frame: 5 years
Plan to share: No
Started May 2022 (actual). Primary completion is estimated for May 2026, 48 months after the start.
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