Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

NCT05326828 | Recruiting DMC

• 1 other identifier: 2022-D0009
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

MINOCA; Atrial Fibrillation

Keywords

Implantable cardiac monitor

Outcome Measures

Primary Outcomes (2)

• ICM group: Atrial fibrillation

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

  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

  1 year

Secondary Outcomes (8)

• ICM group: Time to first diagnosed atrial fibrillation

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

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

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

• ICM group: Atrial fibrillation burden

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

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

  1 year

• ICM group: Other brady- or tachyarrhythmias

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

Study Arms (2)

ICM group

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

Non-ICM group

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

Interventions

CONFIRM Rx implantable cardiac rhythm monitor (Abbott) DEVICE

Implantation of CONFIRM Rx ICM

ICM group

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)

ICM group; Non-ICM group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland

You may qualify if:

• ≥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

You may not qualify if:

• 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
• ≥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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Zürich: collaborator
• Bangerter-Rhyner Stiftung: collaborator
• Abbott: collaborator

Study Sites (2)

Bern University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

University Hospital Zurich USZ

Zurich, 8091, Switzerland

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 Research. Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 30;139(18):e891-e908. doi: 10.1161/CIR.0000000000000670.

  PMID: 30913893 BACKGROUND

• 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 Mar 2.

  PMID: 32114796 BACKGROUND

• 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 in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Montenegro Sa F, Ruivo C, Santos LG, Antunes A, Saraiva F, Soares F, Morais J. Myocardial infarction with nonobstructive coronary arteries: a single-center retrospective study. Coron Artery Dis. 2018 Sep;29(6):511-515. doi: 10.1097/MCA.0000000000000619.

  PMID: 29608443 BACKGROUND

• Abdu FA, Liu L, Mohammed AQ, Luo Y, Xu S, Auckle R, Xu Y, Che W. Myocardial infarction with non-obstructive coronary arteries (MINOCA) in Chinese patients: Clinical features, treatment and 1 year follow-up. Int J Cardiol. 2019 Jul 15;287:27-31. doi: 10.1016/j.ijcard.2019.02.036. Epub 2019 Feb 20.

  PMID: 30826195 BACKGROUND

• Reynolds HR, Maehara A, Kwong RY, Sedlak T, Saw J, Smilowitz NR, Mahmud E, Wei J, Marzo K, Matsumura M, Seno A, Hausvater A, Giesler C, Jhalani N, Toma C, Har B, Thomas D, Mehta LS, Trost J, Mehta PK, Ahmed B, Bainey KR, Xia Y, Shah B, Attubato M, Bangalore S, Razzouk L, Ali ZA, Merz NB, Park K, Hada E, Zhong H, Hochman JS. Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of Myocardial Infarction With Nonobstructive Coronary Arteries in Women. Circulation. 2021 Feb 16;143(7):624-640. doi: 10.1161/CIRCULATIONAHA.120.052008. Epub 2020 Nov 14.

  PMID: 33191769 BACKGROUND

MeSH Terms

Conditions

MINOCA; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Study Officials

• Lorenz Räber, MD, PhD

  Bern University Hospital Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Räber, MD, PhD

CONTACT

+41 31 632 50 00; lorenz.raeber@insel.ch

Sarah Bär, MD

CONTACT

sarah.baer@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 15, 2031
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)