Intracardiac T-wave Alternans and Ischemia

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jose M. Dizon, Columbia University
ClinicalTrials.gov Identifier:
NCT00669552
First received: April 28, 2008
Last updated: April 11, 2013
Last verified: April 2013
Results First Received: February 15, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Ischemia
Intervention: Procedure: Percutaneous coronary intervention

  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
Medtronic Defibrillator Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.

Participant Flow:   Overall Study
    Medtronic Defibrillator  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     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.
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Reporting Groups
  Description
Medtronic Defibrillator Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.

Baseline Measures
    Medtronic Defibrillator  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     4  
Gender  
[units: participants]
 
Female     4  
Male     7  



  Outcome Measures

1.  Primary:   Number of Subjects With Positive T Wave Studies During a Coronary Intervention   [ Time Frame: During the coronary intervention, upto 2 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jose' Dizon, MD
Organization: Columbia University
phone: 212-305-8559
e-mail: jmd11@columbia.edu


No publications provided


Responsible Party: Jose M. Dizon, Columbia University
ClinicalTrials.gov Identifier: NCT00669552     History of Changes
Other Study ID Numbers: AAAC6715
Study First Received: April 28, 2008
Results First Received: February 15, 2013
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board