Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-31 @ 5:40 AM
Study NCT ID:
NCT07058857
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not know either they include in treatment or control group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': 'Before PPCI, 1 day after PPCI, and 30 days after PPCI', 'description': 'Left Ventricular Ejection Fraction measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'Wall Motion Score Index', 'timeFrame': 'Before PPCI, 1 day after PPCI, and 30 days after PPCI', 'description': 'Wall Motion Score Index measured by transthoracic echocardiography'}, {'measure': 'Diastolic Function', 'timeFrame': 'Before PPCI, 1 day after PPCI, and 30 days after PPCI', 'description': 'Diastolic Function measured by transthoracic echocardiography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ST-segment elevation myocardial infarction', 'Low level tragus stimulation', 'Left ventricular ejection fraction', 'Wall motion score index'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '28797427', 'type': 'BACKGROUND', 'citation': 'Yu L, Huang B, Po SS, Tan T, Wang M, Zhou L, Meng G, Yuan S, Zhou X, Li X, Wang Z, Wang S, Jiang H. 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. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1511-1520. doi: 10.1016/j.jcin.2017.04.036.'}, {'pmid': '30217648', 'type': 'BACKGROUND', 'citation': 'Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on echocardiographic parameter in patient with ST-segment Elevation Myocardial Infarction (STEMI) who undergo primart percutaneous coronary intervention (PPCI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control:\n\nDoes LLTS could alter left ventricular ejection fraction in patients with STEMI? Does LLTS could alter wall motion score index in patients with STEMI? Does LLTS could alter diastolic dysfunction in patients with STEMI?\n\nResearchers will compare LLTS to sham LLTS control to see if LLTS have benefit in participants with STEMI participants will divided into two group i.e. treatment group vs control (sham/placebo) group..\n\nBoth groups undergo transthoracal echocardiographi examination before and after PPCI..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Onset STEMI less than 12 hours\n* Participant agreed to be included in this study\n* Killip class I - II on presentation\n* SBP \\>90 mmHg and/or MAP \\>65 mmHg\n* Sinus rhtyhm\n\nExclusion Criteria:\n\n* History of myocardial infarction, stroke, heart failure with reduce ejection fraction, chronic total occlussion on prior coronary angiography, chronic kidney disease (eGFR \\< 30) or on hemodyalisis, malignancy, hematology disease, autoimmune, or other chronic diseases\n* On permanent pacemaker\n* Acute infection\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT07058857', 'acronym': 'ELITE-STEMI', 'briefTitle': 'The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Diponegoro'}, 'officialTitle': 'The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Undip_Kardio 5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Level Tragus Stimulation Group', 'description': 'Participant will undergo low level tragus stimulation using Parasym Device', 'interventionNames': ['Device: Parasym Neuromodulation Device (Treatment Group)', 'Device: Parasym Neuromodulation Device (Sham Group)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control Group', 'description': 'Participant will have Parasym Device implanted in their tragus without any active stimulation from the device', 'interventionNames': ['Device: Parasym Neuromodulation Device (Treatment Group)', 'Device: Parasym Neuromodulation Device (Sham Group)']}], 'interventions': [{'name': 'Parasym Neuromodulation Device (Treatment Group)', 'type': 'DEVICE', 'description': 'Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device', 'armGroupLabels': ['Low Level Tragus Stimulation Group', 'Sham Control Group']}, {'name': 'Parasym Neuromodulation Device (Sham Group)', 'type': 'DEVICE', 'description': 'Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes', 'armGroupLabels': ['Low Level Tragus Stimulation Group', 'Sham Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Semarang', 'state': 'Central of Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Leo Deddy Pradipta', 'role': 'CONTACT', 'email': 'dancingdeagle@gmail.com', 'phone': '+6281316499074'}], 'facility': 'Dr. Kariadi Central General Hospital', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'centralContacts': [{'name': 'Leo Deddy Pradipta', 'role': 'CONTACT', 'email': 'dancingdeagle@gmail.com', 'phone': '+6281316499074'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Diponegoro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro', 'investigatorFullName': 'Sodiqur Rifqi', 'investigatorAffiliation': 'Universitas Diponegoro'}}}}