MINOCAMINOCANCT05326828
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
An observational study of MINOCA and Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- MINOCA, Atrial Fibrillation
- What is being tested?
- CONFIRM Rx implantable cardiac rhythm monitor (Abbott) and Systematic etiologic work-up for underlying causes of MINOCA
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 24 May 2022to 15 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland
Who may be able to join
- ≥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)
Show all 13Show fewer
- No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation
- ≥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
Who cannot join
- 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)
Show all 14Show fewer
- 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
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Bär, MD contact
Switzerland2 sites, 2 recruiting
- Recruiting
Bern University Hospital Inselspital
Bern, 3010
Lorenz Räber, MD, PhD, +41 31 632 09 29, lorenz.raeber@insel.ch
Sarah Bär, MD, +41 31 632 21 11, sarah.baer@insel.ch
- Recruiting
University Hospital Zurich USZ
Zurich, 8091
Barbara Stähli, MD, +41 43 253 05 97, barbara.staehli@usz.ch
Barbara Stähli, MD
About this study
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.
Read the 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.
- Conditions
- MINOCA, Atrial Fibrillation
- Being tested
- CONFIRM Rx implantable cardiac rhythm monitor (Abbott), Systematic etiologic work-up for underlying causes of MINOCA
- Keywords
- Implantable cardiac monitor
- Medical subject headings
- MINOCA, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONFIRM Rx implantable cardiac rhythm monitor (Abbott)Device
Implantation of CONFIRM Rx ICM
Systematic etiologic work-up for underlying causes of MINOCADiagnostic test
Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)
| Study group | Role | What they receive |
|---|---|---|
| ICM group | Patients eligible for ICM implantation for screening of atrial fibrillation Receives: 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. Receives: Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICM group: Atrial fibrillation
The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM
Measured: 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
Measured: 1 year
Secondary outcomes (8)
ICM group: Time to first diagnosed atrial fibrillation
Time to first occurrence of atrial fibrillation according to ICM
Measured: ~2 years (battery end of life or explantation of ICM)
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)
Measured: ~2 years (battery end of life or explantation of ICM)
ICM group: Atrial fibrillation burden
Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)
Measured: ~2 years (battery end of life or explantation of ICM)
ICM group: First diagnosis of atrial fibrillation, stroke or death
Time to composite of first diagnosis of atrial fibrillation, stroke or death
Measured: 1 year
ICM group: Other brady- or tachyarrhythmias
The incidence and time to first occurrence of other brady- or tachyarrhythmias
Measured: ~2 years (battery end of life or explantation of ICM)
ICM group: Predictive value of CMR parameters for atrial fibrillation
Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation
Measured: ~2 years (battery end of life or explantation of ICM)
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
Measured: 1 year
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start24 May 2022
- Primary completion24 May 2026 (estimated)
- Study completion15 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MINOCAStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Bangerter-Rhyner Stiftung, Abbott
- Responsible party
- Sponsor
- Investigators
- Lorenz Räber, MD, PhD, Principal investigator, Bern University Hospital Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326828
- Sponsor's protocol ID
- 2022-D0009
- Acronym
- MINOCA
- Status last verified
- Oct 2024
- First submitted
- 6 Apr 2022
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28158518Tamis-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.
PubMed 30913893Diederichsen 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.
PubMed 32114796Hindricks 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.
PubMed 32860505Smilowitz 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.
PubMed 29246884Pasupathy 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.
PubMed 25587100Barr 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.
PubMed 28408093Safdar 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.
PubMed 29954744Montenegro 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.
PubMed 29608443Abdu 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.
PubMed 30826195Reynolds 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.
PubMed 33191769
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
- ClinicalTrials.gov ID
- NCT05326828
- Acronym / sponsor ID
- MINOCA / 2022-D0009
- Conditions
- MINOCA, Atrial Fibrillation
- Keywords
- Implantable cardiac monitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Bangerter-Rhyner Stiftung, Abbott
- Study start
- 24 May 2022 (actual)
- Primary completion
- 24 May 2026 (estimated)
- Study completion
- 15 May 2031 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICM group | – | Device: CONFIRM Rx implantable cardiac rhythm monitor (Abbott), Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCAPatients eligible for ICM implantation for screening of atrial fibrillation |
| Non-ICM group | – | Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCAPatients ineligible for ICM implantation due to 1) refusal, 2) contraindication, or 3) clear underlying cause of MINOCA before ICM implantation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland
Key inclusion criteria (13 listed)
- ≥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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONFIRM Rx implantable cardiac rhythm monitor (Abbott)Implantation of CONFIRM Rx ICM | Device | ICM group |
| Systematic etiologic work-up for underlying causes of MINOCAIntracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group) | Diagnostic test | ICM group, Non-ICM group |
Primary outcome
ICM group: Atrial fibrillation
Time frame: 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
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
8 secondary outcomes
ICM group: Time to first diagnosed atrial fibrillation
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Time to different durations of first diagnosed atrial fibrillation
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Atrial fibrillation burden
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: First diagnosis of atrial fibrillation, stroke or death
Time frame: 1 year
ICM group: Other brady- or tachyarrhythmias
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Predictive value of CMR parameters for atrial fibrillation
Time frame: ~2 years (battery end of life or explantation of ICM)
ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA
Time frame: 1 year
Both groups: Clinical outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Background: PubMed 28158518Agewall 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.
- Background: PubMed 30913893Tamis-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.
- Background: PubMed 32114796Diederichsen 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.
- Background: PubMed 32860505Hindricks 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.
- Background: PubMed 29246884Smilowitz 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.
- Background: PubMed 25587100Pasupathy 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.
- Background: PubMed 28408093Barr 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.
- Background: PubMed 29954744Safdar 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.
- Background: PubMed 29608443Montenegro 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.
- Background: PubMed 30826195Abdu 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.
- Background: PubMed 33191769Reynolds 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Bär, MD contact
Lorenz Räber, MD, PhD principal investigator
Bern University Hospital Inselspital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MINOCA and Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Räber, MD, PhD (+41 31 632 50 00, lorenz.raeber@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICM group: Atrial fibrillation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326828, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.