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Completed

NCT Number: NCT01597557

Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of New York at Buffalo

Buffalo, New York, 14214, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

Drug

2 grams intravenous drip over 30 minutes

Placebo

Other

Normal Saline 50 ml intravenous drip over 30 minutes

Primary outcomes

  1. Number of Participants With Successful Cardioversion of Atrial Fibrillation to Sinus Rhythm

    Time frame: One hour after cardioversion

    Successful cardioversion involves conversion of atrial fibrillation to sinus rhythm and maintenance of sinus rhythm for one hour

Secondary outcomes

  1. Total Amount of Energy Required for Successful Cardioversion of the Atrial Fibrillation to Sinus Rhythm

    Time frame: One hour

  2. Number of Participants Who Experienced Severe Hypotensive Episodes After Infusion of Magnesium Sulfate or Placebo

    Time frame: 30 minutes

    Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Acronym: MICA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 14, 2012
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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