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NCT Number: NCT05326828

Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital Inselspital, Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ICM group

  • ≥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
  • No clinically overt specific cause for the acute presentation
  • Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)
  • No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation

Exclusion criteria

ICM group:

  • Known atrial fibrillation or atrial flutter
  • History of atrial fibrillation or atrial flutter ablation
  • Known coronary artery disease
  • Previous MI
  • Previous percutaneous coronary intervention (PCI)
  • Previous coronary artery bypass grafting (CABG)
  • Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) <30 ml/min)
  • Contraindications to ICM implantation
  • Clear underlying cause of MINOCA before ICM implantation

Inclusion criteria

non-ICM group:

  • ≥18 years of age
  • Written informed consent
  • 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
  • No clinically overt specific cause for the acute presentation
  • Subendocardial or transmural LGE consistent with an ischemic etiology on CMR

Exclusion criteria

non-ICM group:

  • Known coronary artery disease
  • Previous MI
  • Previous PCI
  • Previous CABG
  • Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR <30 ml/min)

Treatment and study plan

CONFIRM Rx implantable cardiac rhythm monitor (Abbott)

Device

Implantation of CONFIRM Rx ICM

Systematic etiologic work-up for underlying causes of MINOCA

Diagnostic Test

Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)

Primary outcomes

  1. ICM group: Atrial fibrillation

    Time frame: 1 year

    The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM

  2. Non-ICM group: Frequency of underlying causes of MINOCA

    Time frame: 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 outcomes

  1. ICM group: Time to first diagnosed atrial fibrillation

    Time frame: ~2 years (battery end of life or explantation of ICM)

    Time to first occurrence of atrial fibrillation according to ICM

  2. ICM group: Time to different durations of first diagnosed atrial fibrillation

    Time frame: ~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)

  3. ICM group: Atrial fibrillation burden

    Time frame: ~2 years (battery end of life or explantation of ICM)

    Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)

  4. ICM group: First diagnosis of atrial fibrillation, stroke or death

    Time frame: 1 year

    Time to composite of first diagnosis of atrial fibrillation, stroke or death

  5. ICM group: Other brady- or tachyarrhythmias

    Time frame: ~2 years (battery end of life or explantation of ICM)

    The incidence and time to first occurrence of other brady- or tachyarrhythmias

  6. ICM group: Predictive value of CMR parameters for atrial fibrillation

    Time frame: ~2 years (battery end of life or explantation of ICM)

    Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation

  7. ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA

    Time frame: 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

  8. Both groups: Clinical outcomes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenz Räber, MD, PhD

CONTACT

[email protected]

+41 31 632 50 00

Sarah Bär, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Abbott
  • Bangerter-Rhyner Stiftung
  • University Hospital, Zürich

Registry information

Acronym: MINOCA

Important dates

Study start
2022
Primary completion
2026
Study completion
2031
First posted
Apr 14, 2022
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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