Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство CONFIRM Rx implantable cardiac rhythm monitor (Abbott)
  Implantation of CONFIRM Rx ICM
• Диагностический тест Systematic etiologic work-up for underlying causes of MINOCA
  Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)

Первичные конечные точки

• ICM group: Atrial fibrillation [Срок оценки: 1 year]
• Non-ICM group: Frequency of underlying causes of MINOCA [Срок оценки: 1 year]

Вторичные конечные точки (8)

• ICM group: Time to first diagnosed atrial fibrillation [Срок оценки: ~2 years (battery end of life or explantation of ICM)]
• ICM group: Time to different durations of first diagnosed atrial fibrillation [Срок оценки: ~2 years (battery end of life or explantation of ICM)]
• ICM group: Atrial fibrillation burden [Срок оценки: ~2 years (battery end of life or explantation of ICM)]
• ICM group: First diagnosis of atrial fibrillation, stroke or death [Срок оценки: 1 year]
• ICM group: Other brady- or tachyarrhythmias [Срок оценки: ~2 years (battery end of life or explantation of ICM)]
• ICM group: Predictive value of CMR parameters for atrial fibrillation [Срок оценки: ~2 years (battery end of life or explantation of ICM)]
• ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA [Срок оценки: 1 year]
• Both groups: Clinical outcomes [Срок оценки: 5 years]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• Bern University Hospital Inselspital — Bern
• University Hospital Zurich USZ — Zurich

Публикации

• Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149. No abstract available. PMID 28158518
• Tamis-Holland JE, Jneid H, Reynolds HR, Agewall S, Brilakis ES, Brown TM, Lerman A, Cushman M, Kumbhani DJ, Arslanian-Engoren C, Bolger AF, Beltrame JF; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Resear PMID 30913893
• Diederichsen SZ, Haugan KJ, Kronborg C, Graff C, Hojberg S, Kober L, Krieger D, Holst AG, Nielsen JB, Brandes A, Svendsen JH. Comprehensive Evaluation of Rhythm Monitoring Strategies in Screening for Atrial Fibrillation: Insights From Patients at Risk Monitored Long Term With an Implantable Loop Recorder. Circulation. 2020 May 12;141(19):1510-1522. doi: 10.1161/CIRCULATIONAHA.119.044407. Epub 2020 PMID 32114796
• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed PMID 32860505
• Smilowitz NR, Mahajan AM, Roe MT, Hellkamp AS, Chiswell K, Gulati M, Reynolds HR. Mortality of Myocardial Infarction by Sex, Age, and Obstructive Coronary Artery Disease Status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines). Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e003443. doi: 10.1161/CIRCOUTCOMES.116.003443. PMID 29246884
• Pasupathy S, Air T, Dreyer RP, Tavella R, Beltrame JF. Systematic review of patients presenting with suspected myocardial infarction and nonobstructive coronary arteries. Circulation. 2015 Mar 10;131(10):861-70. doi: 10.1161/CIRCULATIONAHA.114.011201. Epub 2015 Jan 13. PMID 25587100
• Barr PR, Harrison W, Smyth D, Flynn C, Lee M, Kerr AJ. Myocardial Infarction Without Obstructive Coronary Artery Disease is Not a Benign Condition (ANZACS-QI 10). Heart Lung Circ. 2018 Feb;27(2):165-174. doi: 10.1016/j.hlc.2017.02.023. Epub 2017 Mar 30. PMID 28408093
• Safdar B, Spatz ES, Dreyer RP, Beltrame JF, Lichtman JH, Spertus JA, Reynolds HR, Geda M, Bueno H, Dziura JD, Krumholz HM, D'Onofrio G. Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study. J Am Heart Assoc. 2018 Jun 28;7(13):e009174. doi: 10.1161/JAHA.118.009174. PMID 29954744

Идентификаторы

NCT: NCT05326828 · 2022-D0009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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