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T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00589849
First received: December 28, 2007
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
Results First Received: August 3, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Myocardial Infarction
Arrhythmias
Intervention: Procedure: T-wave Alternans

  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
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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
T Wave Altenans Stress Test No text entered.

Participant Flow:   Overall Study
    T Wave Altenans Stress Test  
STARTED     32  
COMPLETED     32  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
T Wave Altenans Stress Test No text entered.

Baseline Measures
    T Wave Altenans Stress Test  
Number of Participants  
[units: participants]
 		  32  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation 		  58  ± 13.04  
Gender  
[units: participants]
 		 
Female     11  
Male     21  
Region of Enrollment  
[units: participants]
 		 
United States     32  



  Outcome Measures

1.  Primary:   Event Free Survival at 1 Year   [ Time Frame: 12 months ]
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2.  Primary:   Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI   [ Time Frame: 30 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Dr. Aryan Mooss
Organization: Creighton University
phone: 402-280-4566
e-mail: aryanmooss@creighton.edu


No publications provided


Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00589849     History of Changes
Other Study ID Numbers: 05-13651, 05-13651
Study First Received: December 28, 2007
Results First Received: August 3, 2011
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board