Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Atrial Fibrillation Clinical Trial

— MINOCA  

Official title:

Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326828
• Other study ID #: 2022-D0009
• Status: Recruiting
• Start date: May 24, 2022
• Est. completion date: May 15, 2029

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Lorenz Räber, MD, PhD
• Phone: +41 31 632 50 00
• Email: lorenz.raeber[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2029
• Est. primary completion date: May 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria ICM group

1. =18 years of age

2. Written informed consent

3. Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction

4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses =50% in any potential infarct-related artery

5. No clinically overt specific cause for the acute presentation

6. Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)

7. No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation

Exclusion Criteria ICM group:

1. Known atrial fibrillation or atrial flutter

2. History of atrial fibrillation or atrial flutter ablation

3. Known coronary artery disease

4. Previous MI

5. Previous percutaneous coronary intervention (PCI)

6. Previous coronary artery bypass grafting (CABG)

7. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) <30 ml/min)

8. Contraindications to ICM implantation

9. Clear underlying cause of MINOCA before ICM implantation

Inclusion Criteria non-ICM group:

1. =18 years of age

2. Written informed consent

3. AMI type 1 in accordance with the 4th universal definition of myocardial infarction

4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses =50% in any potential infarct-related artery

5. No clinically overt specific cause for the acute presentation

6. Subendocardial or transmural LGE consistent with an ischemic etiology on CMR

Exclusion Criteria non-ICM group:

1. Known coronary artery disease

2. Previous MI

3. Previous PCI

4. Previous CABG

5. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR <30 ml/min)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• CONFIRM Rx implantable cardiac rhythm monitor (Abbott)
Implantation of CONFIRM Rx ICM

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Switzerland	Bern University Hospital Inselspital	Bern
Switzerland	University Hospital Zurich USZ	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Abbott, Bangerter-Rhyner Stiftung, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

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. — View Citation

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. Erratum In: Circulation. 2015 May 12;131(19):e475. — View Citation

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. Erratum In: Circulation. 2023 Feb 21;147(8):e624. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICM group: Atrial fibrillation	The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM	1 year
Primary	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	ICM group: Time to first diagnosed atrial fibrillation	Time to first occurrence of atrial fibrillation according to ICM	~2 years (battery end of life or explantation of ICM)
Secondary	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)	~2 years (battery end of life or explantation of ICM)
Secondary	ICM group: Atrial fibrillation burden	Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)	~2 years (battery end of life or explantation of ICM)
Secondary	ICM group: First diagnosis of atrial fibrillation, stroke or death	Time to composite of first diagnosis of atrial fibrillation, stroke or death	1 year
Secondary	ICM group: Other brady- or tachyarrhythmias	The incidence and time to first occurrence of other brady- or tachyarrhythmias	~2 years (battery end of life or explantation of ICM)
Secondary	ICM group: Predictive value of CMR parameters for atrial fibrillation	Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation	~2 years (battery end of life or explantation of ICM)
Secondary	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	1 year
Secondary	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	5 years