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Automatic External Defibrillation Monitoring in Cardiac Arrest

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
A. Maziar Zafari, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00382928
First received: September 29, 2006
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Death, Sudden, Cardiac
Ventricular Fibrillation
Tachycardia, Ventricular
Intervention: Device: Defibrillation of pulseless VT/VF by AECD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One hundred and ninety two patients were recruited in the time period between 10/10/2006 to 7/20/2007 to the telemetry ward of the Atlanta VA Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
No Intervention: Standard of Care Group Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
Experimental: AECD Monitoring + Standard of Care Group Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.

Participant Flow:   Overall Study
    No Intervention: Standard of Care Group   Experimental: AECD Monitoring + Standard of Care Group
STARTED   97   95 
COMPLETED   97   95 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Intervention: Standard of Care Group Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Experimental: AECD Monitoring + Standard of Care Group Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Total Total of all reporting groups

Baseline Measures
   No Intervention: Standard of Care Group   Experimental: AECD Monitoring + Standard of Care Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   95   192 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   97   95   192 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (3.4)   61.7  (3.4)   61.9  (3.4) 
Gender 
[Units: Participants]
     
Female   3   3   6 
Male   94   92   186 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   0   2   2 
White   53   42   95 
Black   44   51   95 
Clinical Characteristics of Study Subjects 
[Units: Participants]
     
History of Heart Failure   20   25   45 
New Diagnosis of Heart Failure   4   6   10 
Diabetes mellitus   35   46   81 
History of Coronary Artery Disease   42   35   77 
Hypertension   74   79   153 
Hyperlipidemia   53   55   108 
EKG on admission 
[Units: Participants]
     
normal sinus rhythm   81   84   165 
Atrial fibrillation/flutter   11   9   20 
supraventricular tachycardia   2   0   2 
Other   3   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Without Defibrillation   [ Time Frame: 10 minutes ]

2.  Secondary:   Frequency of Abnormal Rhythms Monitored by the AECD   [ Time Frame: During the duration of hospital admission on the telemetry ward. ]

3.  Secondary:   Survival to Discharge   [ Time Frame: At discharge ]

4.  Secondary:   Cerebral Performance at Discharge   [ Time Frame: At discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. A. Maziar Zafari
Organization: Atlanta Research and Education Foundation
phone: 404-321-6111 ext 4019
e-mail: azafari@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A. Maziar Zafari, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00382928     History of Changes
Other Study ID Numbers: 1216-2004
Study First Received: September 29, 2006
Results First Received: December 12, 2013
Last Updated: June 22, 2015