Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 1:26 AM
Study NCT ID:
NCT01597557
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2012-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abcurtis@buffalo.edu', 'phone': '716-859-4828', 'title': 'Dr. Anne Curtis', 'organization': 'University at Buffalo'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Very few patients in paroxysmal AF, majority failed earlier rhythm control strategies making the study population a resistant population to treat, only one dose of Mg infusion was tested and the monitoring period was only 1 hour post cardioversion'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes', 'otherNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes', 'otherNumAtRisk': 129, 'otherNumAffected': 0, 'seriousNumAtRisk': 129, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One hour after cardioversion', 'description': 'Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '123.3', 'spread': '55.5', 'groupId': 'OG000'}, {'value': '129.5', 'spread': '52.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One hour', 'unitOfMeasure': 'Joules', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure per protocol and were excluded in this analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Severe hypotensive episode with a Systolic BP \\< 90mm hg with \\> 20 mm Hg drop after infusion of the study drug or placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Did not undergo cardioversion procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure due to various reasons'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure\n\nMagnesium Sulfate: 2 grams intravenous drip over 30 minutes'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure\n\nPlacebo: Normal Saline 50 ml intravenous drip over 30 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2012-05-10', 'resultsFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-29', 'studyFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm', 'timeFrame': 'One hour after cardioversion', 'description': 'Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour'}], 'secondaryOutcomes': [{'measure': 'Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm', 'timeFrame': 'One hour'}, {'measure': 'Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo', 'timeFrame': '30 minutes', 'description': 'Severe hypotensive episode with a Systolic BP \\< 90mm hg with \\> 20 mm Hg drop after infusion of the study drug or placebo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Electrical Cardioversion', 'Magnesium Sulfate'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '27586232', 'type': 'DERIVED', 'citation': 'Rajagopalan B, Shah Z, Narasimha D, Bhatia A, Kim CH, Switzer DF, Gudleski GH, Curtis AB. Efficacy of Intravenous Magnesium in Facilitating Cardioversion of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2016 Sep;9(9):e003968. doi: 10.1161/CIRCEP.116.003968.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for successful cardioversion of atrial fibrillation into sinus rhythm.', 'detailedDescription': 'Patients with atrial fibrillation may suffer from disabling symptoms such as palpitations, shortness of breath or worsening heart failure. In such patients, it may be beneficial to convert their rhythm to sinus rhythm. Cardioversion can be achieved either pharmacologically or electrically. Pharmacological cardioversion is less successful acutely than electrical cardioversion and may be associated with complications such as prolongation of the QT interval and torsades de pointes (polymorphic ventricular tachycardia). Thus, cardioversion is most often accomplished electrically, using biphasic synchronized shocks of 75-200 Joules. Biphasic electrical cardioversion in atrial fibrillation has shown to be successful (i.e., converting to sinus rhythm) about 88% of the time, on average. The success rate appears to largely depend upon the duration of the arrhythmia and the presence and severity of structural heart disease.\n\nIn this study, we will evaluate the effect of intravenous magnesium sulfate on the success rate of electrical cardioversion, and also assess its effect in decreasing the energy levels needed for successful cardioversion. If the study is successful, we will have shown that a simple and inexpensive intervention can increase the success rate of electrical cardioversion, increasing the proportion of patients who can be restored to sinus rhythm. In addition, success with lower energy levels may improve the safety of cardioversion, as high energy levels are more likely to be associated with side effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion.\n* Patients with atrial fibrillation longer than 48 hours on warfarin with documented therapeutic INR levels \\>2 for at least 3 weeks prior to the cardioversion, or been on dabigatran for 3 weeks, or a transesophageal echocardiogram on the day of the procedure that excludes intracardiac thrombi, undergoing electrical cardioversion.\n\nExclusion Criteria:\n\n* Creatinine \\>2.0 mg/dl\n* Potassium level less than 3.5 mmol/dl\n* TSH \\< 0.5\n* Magnesium levels \\>3.0 mg/dl\n* Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema)\n* Patients with recent (less than 6 weeks) acute myocardial infarction\n* Patients post-cardiac surgery\n* Pregnant women\n* Patients who are being treated with antiarrhythmic drugs who have received less than five doses of the drug. For amiodarone, patients who have received less than three weeks prior to cardioversion are excluded.'}, 'identificationModule': {'nctId': 'NCT01597557', 'acronym': 'MICA', 'briefTitle': 'Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial', 'orgStudyIdInfo': {'id': 'MED7441011B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium Sulfate', 'description': 'Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this arm receive normal saline drip intravenously before the cardioversion procedure', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': '2 grams intravenous drip over 30 minutes', 'armGroupLabels': ['Magnesium Sulfate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal Saline 50 ml intravenous drip over 30 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Anne B Curtis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York at Buffalo'}, {'name': 'Bharath Rajagopalan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York at Buffalo'}, {'name': 'Anne B Curtis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'State University of New York at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Anne Curtis', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}