Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
- Conditions
- MINOCAAtrial Fibrillation
- Interventions
- Device: CONFIRM Rx implantable cardiac rhythm monitor (Abbott)Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA
- Registration Number
- NCT05326828
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICM group Systematic etiologic work-up for underlying causes of MINOCA Patients eligible for ICM implantation for screening of atrial fibrillation ICM group CONFIRM Rx implantable cardiac rhythm monitor (Abbott) Patients eligible for ICM implantation for screening of atrial fibrillation Non-ICM group 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.
- Primary Outcome Measures
Name Time Method ICM group: Atrial fibrillation 1 year The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM
Non-ICM group: Frequency of underlying causes of MINOCA 1 year 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
- Secondary Outcome Measures
Name Time Method Both groups: Clinical outcomes 5 years 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
ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA 1 year 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
ICM group: Other brady- or tachyarrhythmias ~2 years (battery end of life or explantation of ICM) The incidence and time to first occurrence of other brady- or tachyarrhythmias
ICM group: Time to first diagnosed atrial fibrillation ~2 years (battery end of life or explantation of ICM) Time to first occurrence of atrial fibrillation according to ICM
ICM group: Atrial fibrillation burden ~2 years (battery end of life or explantation of ICM) Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)
ICM group: First diagnosis of atrial fibrillation, stroke or death 1 year Time to composite of first diagnosis of atrial fibrillation, stroke or death
ICM group: Predictive value of CMR parameters for atrial fibrillation ~2 years (battery end of life or explantation of ICM) Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation
ICM group: Time to different durations of first diagnosed atrial fibrillation ~2 years (battery end of life or explantation of ICM) Time to first diagnosis of atrial fibrillation (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour)
Trial Locations
- Locations (2)
Bern University Hospital Inselspital
🇨🇭Bern, Switzerland
University Hospital Zurich USZ
🇨🇭Zürich, Switzerland