Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT02982434
Status:
UNKNOWN
Last Update Posted:
2016-12-05
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from any atrial tachyarrhythmias', 'timeFrame': '12 months', 'description': 'Recurrence of \\>30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug'}], 'secondaryOutcomes': [{'measure': 'number of deaths', 'timeFrame': '12 month'}, {'measure': 'time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU', 'timeFrame': '1 month'}, {'measure': 'incidence of congestive heart failure', 'timeFrame': '12 month'}, {'measure': 'incidence of sustained ventricular arrhythmias', 'timeFrame': '12 month'}, {'measure': 'stroke or transient ischemic attack', 'timeFrame': '12 month'}, {'measure': 'incidence of myocardial infarction', 'timeFrame': '12 month'}, {'measure': 'rehospitalization', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'botulinum toxin', 'ischemic heart disease'], 'conditions': ['Atrial Fibrillation', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)\n* At least one failed antiarrhythmic drug\n* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery\n\nExclusion Criteria:\n\nPrevious heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT02982434', 'briefTitle': 'The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'RSTD_021216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP', 'interventionNames': ['Drug: Pharmaceutical composition containing botulinum toxin', 'Procedure: Coronary artery bypass grafting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP', 'interventionNames': ['Drug: 0.9% normal saline', 'Procedure: Coronary artery bypass grafting']}], 'interventions': [{'name': 'Pharmaceutical composition containing botulinum toxin', 'type': 'DRUG', 'armGroupLabels': ['Group 1']}, {'name': '0.9% normal saline', 'type': 'DRUG', 'armGroupLabels': ['Group 2']}, {'name': 'Coronary artery bypass grafting', 'type': 'PROCEDURE', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander Romanov, MD, PhD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+73833327655'}, {'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+73833327655'}], 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Tomsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Boris Kozlov, MD', 'role': 'CONTACT', 'email': 'cardio@cardio-tomsk.ru', 'phone': '7(3822) 55 35 96'}], 'facility': 'Cardiology Research Institute', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'centralContacts': [{'name': 'Alexander Romanov, MD, PhD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+73833327655'}, {'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+73833327655'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}