Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

Atrial Fibrillation Clinical Trial

— MICA  

Official title:

Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597557
• Other study ID #: MED7441011B
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Magnesium Sulfate
2 grams intravenous drip over 30 minutes

Other:
• Placebo
Normal Saline 50 ml intravenous drip over 30 minutes

Locations

Country	Name	City	State
United States	State University of New York at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm		One hour
Secondary	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