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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Magnesium Sulfate; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • State University of New York at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium Sulfate; Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure	Drug: Magnesium Sulfate; 2 grams intravenous drip over 30 minutes
Placebo Comparator: Placebo; Patients in this arm receive normal saline drip intravenously before the cardioversion procedure	Other: Placebo; Normal Saline 50 ml intravenous drip over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One hour after cardioversion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm		One hour
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	30 minutes

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Anne B Curtis, MD, State University of New York at Buffalo; Principal Investigator: Bharath Rajagopalan, MBBS, State University of New York at Buffalo; Study Chair: Anne B Curtis, MD, State University of New York at Buffalo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 14, 2012

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Magnesium Sulfate; Electrical Cardioversion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: MED7441011B