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 30, 2014
Last verified: May 2014
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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  
Number of Participants  
[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


No publications provided


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 30, 2014
Health Authority: United States: Institutional Review Board