Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 5:57 PM
Study NCT ID:
NCT05992259
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Vagus Stimulation and STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization of active stimulation vs. sham stimulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of the level of myocardial damage.', 'timeFrame': 'Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.', 'description': 'Dynamics of Troponin I (hs-cTnI) in blood plasma.'}, {'measure': 'Assessment of the level of inflammation.', 'timeFrame': 'Diagnosis will be carried out during hospitalization and after 24 hours.', 'description': 'Dynamics of high-sensitivity C-reactive protein (hs-CRP) in blood plasma. Dynamics of copeptin (CPP) in blood plasma.'}, {'measure': 'Assessment of the level of heart failure', 'timeFrame': 'Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.', 'description': 'Dynamics of NT-proBNP in blood plasma.'}], 'primaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 14 days.', 'description': 'The number of patients who died in the hospital.'}, {'measure': '30-day mortality', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 30 days.', 'description': 'The number of patients who died within 30 days from the development of myocardial infarction.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with non-lethal events.', 'timeFrame': 'From the date of randomization to the date of any of the listed events, assessed up to 14 days.', 'description': 'The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['auricular stimulation', 'auricular vagus nerve stimulation', 'transcutaneous vagus nerve stimulation (TENS)', 'vagus nerve stimulation (VNS)', 'acute coronary syndrome', 'myocardial ischemia reperfusion injury', 'ST-segment elevation myocardial infarction', 'coronary heart disease', 'acute myocardial infarction', 'mortality', 'atrial fibrillation'], 'conditions': ['Vagus Nerve Stimulation', 'Acute Coronary Syndrome', 'Ischemia Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '40142674', 'type': 'DERIVED', 'citation': 'Kruchinova S, Gendugova M, Namitokov A, Sokolskaya M, Gilevich I, Tatarintseva Z, Karibova M, Danilov V, Simakin N, Shvartz E, Kosmacheva E, Shvartz V. Low-Frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve in Patients with ST-Elevation Myocardial Infarction: A Randomized Clinical Trial. J Clin Med. 2025 Mar 10;14(6):1866. doi: 10.3390/jcm14061866.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jcin.2017.04.036', 'label': 'Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept Study'}, {'url': 'https://doi.org/10.1016/j.jcin.2017.05.063', 'label': 'Vagal Cardioprotection in Reperfused Acute Myocardial Infarction'}]}, 'descriptionModule': {'briefSummary': 'At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.', 'detailedDescription': 'ACS is a combined concept for such life-threatening conditions as acute myocardial infarction (AMI) and unstable angina, which are exacerbations of coronary heart disease. However, despite the high effectiveness of the invasive treatment strategy, there remains a high mortality and disability of this group of patients. One of the reasons for this problem is reperfusion injury of the myocardium during revascularization, since reperfusion itself causes myocardial damage, known as Myocardial Ischemia Reperfusion Injury (MIRI). Every year, new data from experimental studies and small clinical trials appear, confirming the concept that MIRI makes a big contribution to the final size of a heart attack and cardiac myocardial function. Currently, there is no specific treatment aimed at MIRI in patients with STEMI. Thus, new treatment methods are needed that can reduce MIRI in revascularized patients. In the course of small clinical studies, it was shown that against the background of vagus nerve stimulation, a significant decrease in heart rate occurs, inflammatory processes and cellular apoptosis are suppressed, left ventricular remodeling decreases and myocardial contractile function improves. Also, a significant decrease in MIRI is demonstrated with percutaneous stimulation of the vagus nerve in the acute period of myocardial infarction. The data of the first clinical trial with VNS in patients with STEMI were published in 2017 (doi:10.1016/j.jcin.2017.04.036). This experimental study increases the likelihood that this noninvasive therapy can be used to treat patients with STEMI who are undergoing primary percutaneous coronary intervention (PCI). New studies are needed to prove the safety and effectiveness of vagus nerve stimulation in patients with STEMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with STEMI who have signed an informed voluntary consent to participate in the study;\n* primary myocardial infarction;\n* treatment in the first 12 hours from the onset of pain syndrome;\n* primary PCI.\n\nExclusion Criteria:\n\n* acute heart failure III-IV;\n* bradyarrhythmias;\n* atrial fibrillation/flutter at the time of switching on;\n* Thrombolytic therapy at the prehospital stage;\n* a history of myocardial infarction;\n* PCI/coronary artery bypass grafting (CABG) in the anamnesis.'}, 'identificationModule': {'nctId': 'NCT05992259', 'briefTitle': 'Auricular Vagus Stimulation and STEMI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakulev Scientific Center of Cardiovascular Surgery'}, 'officialTitle': 'Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': '#12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active TENS', 'description': 'It will be performed attached to the tragus of the left ear.', 'interventionNames': ['Device: TENS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TENS', 'description': 'It will be performed attached to the earlobe of the left ear.', 'interventionNames': ['Device: TENS']}], 'interventions': [{'name': 'TENS', 'type': 'DEVICE', 'description': 'TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.', 'armGroupLabels': ['Active TENS', 'Sham TENS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krasnodar', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sofia Kruchinova, MD, PhD', 'role': 'CONTACT', 'email': 'skruchinova@mail.ru', 'phone': '+79189504597'}], 'facility': 'Scientific Research Institute Ochapovsky Regional Clinical Hospital', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}], 'centralContacts': [{'name': 'Vladimir Shvartz, MD, DM', 'role': 'CONTACT', 'email': 'vashvarts@bakulev.ru', 'phone': '+79032619292'}], 'overallOfficials': [{'name': 'Vladimir Shvartz, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakoulev Scientific Center for Cardiovascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakulev Scientific Center of Cardiovascular Surgery', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DM, Professor', 'investigatorFullName': 'Vladimir A Shvartz, MD', 'investigatorAffiliation': 'Bakulev Scientific Center of Cardiovascular Surgery'}}}}