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Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial (MICA)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Electrical Cardioversion, Magnesium Sulfate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion.
  • 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.

Exclusion Criteria:

  • Creatinine >2.0 mg/dl
  • Potassium level less than 3.5 mmol/dl
  • TSH < 0.5
  • Magnesium levels >3.0 mg/dl
  • Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema)
  • Patients with recent (less than 6 weeks) acute myocardial infarction
  • Patients post-cardiac surgery
  • Pregnant women
  • 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.

Sites / Locations

  • State University of New York at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium Sulfate

Placebo

Arm Description

Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure

Patients in this arm receive normal saline drip intravenously before the cardioversion procedure

Outcomes

Primary Outcome Measures

Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm
Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour

Secondary Outcome Measures

Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm
Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo
Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo

Full Information

First Posted
May 10, 2012
Last Updated
September 29, 2020
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT01597557
Brief Title
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Acronym
MICA
Official Title
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. In 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Electrical Cardioversion, Magnesium Sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Sulfate
Arm Type
Active Comparator
Arm Description
Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this arm receive normal saline drip intravenously before the cardioversion procedure
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
2 grams intravenous drip over 30 minutes
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal Saline 50 ml intravenous drip over 30 minutes
Primary Outcome Measure Information:
Title
Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm
Description
Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour
Time Frame
One hour after cardioversion
Secondary Outcome Measure Information:
Title
Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm
Time Frame
One hour
Title
Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo
Description
Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion. 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. Exclusion Criteria: Creatinine >2.0 mg/dl Potassium level less than 3.5 mmol/dl TSH < 0.5 Magnesium levels >3.0 mg/dl Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema) Patients with recent (less than 6 weeks) acute myocardial infarction Patients post-cardiac surgery Pregnant women 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne B Curtis, MD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bharath Rajagopalan, MBBS
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne B Curtis, MD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Study Chair
Facility Information:
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27586232
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.
Results Reference
derived

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Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

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