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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01597557
First received: May 10, 2012
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Drug: Magnesium Sulfate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Successful cardioversion of atrial fibrillation to sinus rhythm [ Time Frame: One hour after cardioversion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total amount of energy required for successful cardioversion of the atrial fibrillation to sinus rhythm [ Time Frame: Duration of procedure ] [ Designated as safety issue: No ]
  • Incidence of severe hypotensive episodes after infusion of magnesium sulfate or placebo [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Severe hypotensive episode with a Systolic BP < 90mm hg with > 20 mm Hg drop after infusion of the study drug or placebo


Enrollment: 256
Study Start Date: April 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597557

Locations
United States, New York
State University of New York at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01597557     History of Changes
Other Study ID Numbers: MED7441011B
Study First Received: May 10, 2012
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
Atrial Fibrillation
Electrical Cardioversion
Magnesium Sulfate

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 23, 2014