Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT05326828
Status:
RECRUITING
Last Update Posted:
2024-10-30
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088442', 'term': 'MINOCA'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2031-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICM group: Atrial fibrillation', 'timeFrame': '1 year', 'description': 'The occurrence of first diagnosed atrial fibrillation in patients with MINOCA according to ICM'}, {'measure': 'Non-ICM group: Frequency of underlying causes of MINOCA', 'timeFrame': '1 year', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'ICM group: Time to first diagnosed atrial fibrillation', 'timeFrame': '~2 years (battery end of life or explantation of ICM)', 'description': 'Time to first occurrence of atrial fibrillation according to ICM'}, {'measure': 'ICM group: Time to different durations of first diagnosed atrial fibrillation', 'timeFrame': '~2 years (battery end of life or explantation of ICM)', 'description': 'Time to first diagnosis of atrial fibrillation (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour)'}, {'measure': 'ICM group: Atrial fibrillation burden', 'timeFrame': '~2 years (battery end of life or explantation of ICM)', 'description': 'Time spent in atrial fibrillation divided by total rhythm monitoring time x100 (%)'}, {'measure': 'ICM group: First diagnosis of atrial fibrillation, stroke or death', 'timeFrame': '1 year', 'description': 'Time to composite of first diagnosis of atrial fibrillation, stroke or death'}, {'measure': 'ICM group: Other brady- or tachyarrhythmias', 'timeFrame': '~2 years (battery end of life or explantation of ICM)', 'description': 'The incidence and time to first occurrence of other brady- or tachyarrhythmias'}, {'measure': 'ICM group: Predictive value of CMR parameters for atrial fibrillation', 'timeFrame': '~2 years (battery end of life or explantation of ICM)', 'description': 'Predictive value of atrial parameters of CMR imaging for the diagnosis of atrial fibrillation'}, {'measure': 'ICM group: Frequency of non atrial fibrillation related etiologies of MINOCA', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'Both groups: Clinical outcomes', 'timeFrame': '5 years', 'description': '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'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implantable cardiac monitor'], 'conditions': ['MINOCA', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '28158518', 'type': 'BACKGROUND', '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.'}, {'pmid': '30913893', 'type': 'BACKGROUND', '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.'}, {'pmid': '32114796', 'type': 'BACKGROUND', '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.'}, {'pmid': '32860505', 'type': 'BACKGROUND', '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.'}, {'pmid': '29246884', 'type': 'BACKGROUND', '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.'}, {'pmid': '25587100', 'type': 'BACKGROUND', '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.'}, {'pmid': '28408093', 'type': 'BACKGROUND', '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.'}, {'pmid': '29954744', 'type': 'BACKGROUND', '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."}, {'pmid': '29608443', 'type': 'BACKGROUND', '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.'}, {'pmid': '30826195', 'type': 'BACKGROUND', 'citation': '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': '33191769', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nUntreated 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with cardiac magnetic resonance imaging (CMR) confirmed MINOCA at 2 large tertiary care centers in Switzerland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria ICM group\n\n1. ≥18 years of age\n2. Written informed consent\n3. Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction\n4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery\n5. No clinically overt specific cause for the acute presentation\n6. Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)\n7. No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation\n\nExclusion Criteria ICM group:\n\n1. Known atrial fibrillation or atrial flutter\n2. History of atrial fibrillation or atrial flutter ablation\n3. Known coronary artery disease\n4. Previous MI\n5. Previous percutaneous coronary intervention (PCI)\n6. Previous coronary artery bypass grafting (CABG)\n7. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) \\<30 ml/min)\n8. Contraindications to ICM implantation\n9. Clear underlying cause of MINOCA before ICM implantation\n\nInclusion Criteria non-ICM group:\n\n1. ≥18 years of age\n2. Written informed consent\n3. AMI type 1 in accordance with the 4th universal definition of myocardial infarction\n4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery\n5. No clinically overt specific cause for the acute presentation\n6. Subendocardial or transmural LGE consistent with an ischemic etiology on CMR\n\nExclusion Criteria non-ICM group:\n\n1. Known coronary artery disease\n2. Previous MI\n3. Previous PCI\n4. Previous CABG\n5. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR \\<30 ml/min)'}, 'identificationModule': {'nctId': 'NCT05326828', 'acronym': 'MINOCA', 'briefTitle': 'Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients With MINOCA', 'orgStudyIdInfo': {'id': '2022-D0009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICM group', 'description': 'Patients eligible for ICM implantation for screening of atrial fibrillation', 'interventionNames': ['Device: CONFIRM Rx implantable cardiac rhythm monitor (Abbott)', 'Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA']}, {'label': 'Non-ICM group', 'description': 'Patients ineligible for ICM implantation due to 1) refusal, 2) contraindication, or 3) clear underlying cause of MINOCA before ICM implantation.', 'interventionNames': ['Diagnostic Test: Systematic etiologic work-up for underlying causes of MINOCA']}], 'interventions': [{'name': 'CONFIRM Rx implantable cardiac rhythm monitor (Abbott)', 'type': 'DEVICE', 'description': 'Implantation of CONFIRM Rx ICM', 'armGroupLabels': ['ICM group']}, {'name': 'Systematic etiologic work-up for underlying causes of MINOCA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Intracoronary optical coherence tomography, cardiac magnetic resonance imaging, transesophageal echocardiography, vasospasm testing, thrombophilia screening, Holter ECG (only non-ICM group)', 'armGroupLabels': ['ICM group', 'Non-ICM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Lorenz Räber, MD, PhD', 'role': 'CONTACT', 'email': 'lorenz.raeber@insel.ch', 'phone': '+41 31 632 09 29'}, {'name': 'Sarah Bär, MD', 'role': 'CONTACT', 'email': 'sarah.baer@insel.ch', 'phone': '+41 31 632 21 11'}], 'facility': 'Bern University Hospital Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Barbara Stähli, MD', 'role': 'CONTACT', 'email': 'barbara.staehli@usz.ch', 'phone': '+41 43 253 05 97'}, {'name': 'Barbara Stähli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Zurich USZ', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Lorenz Räber, MD, PhD', 'role': 'CONTACT', 'email': 'lorenz.raeber@insel.ch', 'phone': '+41 31 632 50 00'}, {'name': 'Sarah Bär, MD', 'role': 'CONTACT', 'email': 'sarah.baer@insel.ch'}], 'overallOfficials': [{'name': 'Lorenz Räber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital Inselspital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}, {'name': 'Bangerter-Rhyner Stiftung', 'class': 'UNKNOWN'}, {'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}