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

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ClinicalTrials.gov Identifier: NCT00589849
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date December 28, 2007
First Posted Date January 10, 2008
Results First Submitted Date August 3, 2011
Results First Posted Date October 5, 2011
Last Update Posted Date October 5, 2011
Study Start Date May 2006
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2011)
  • Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI [ Time Frame: 30 days ]
  • Event Free Survival at 1 Year [ Time Frame: 12 months ]
    Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year
Original Primary Outcome Measures
 (submitted: January 9, 2008)
Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT00589849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy
Official Title T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy
Brief Summary T-wave alternans is an electrocardiographic finding that has been shown to predict the occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is unknown about T-wave alternans testing is when is the best time to perform the test. In most studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is unknown if T-wave alternans testing performed prior to hospital discharge in heart attack patients is reliable. The objective of this project is to determine the diagnostic accuracy of T-wave alternans testing performed prior to hospital discharge and again at 30 days after hospital discharge in patients who have suffered a heart attack.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized patients
Condition
  • Myocardial Infarction
  • Arrhythmias
Intervention Procedure: T-wave Alternans
T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave
Study Groups/Cohorts 1
Intervention: Procedure: T-wave Alternans
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2011)
32
Original Estimated Enrollment
 (submitted: January 9, 2008)
60
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Acute Myocardial Infarction (MI) confirmed by electrocardiographic and or/ enzymatic criteria
  • Patients with a left ventricular ejection fraction of 45% or less

Exclusion Criteria:

  • Patients with (1) atrial fibrillation, (2) pacemaker rhythm, (3) left bundle branch block, (4) class III-IV heart failure, (5) inability to achieve a target heart rate with exercise or handgrip stress or (6) spontaneous sustained ventricular tachycardia/ventricular fibrillation will be excluded
  • Patients with recurrent angina pectoris, MI, coronary revascularization, or any other adverse cardiovascular event in the 30 days following their initial MI will also be excluded
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00589849
Other Study ID Numbers 05-13651
05-13651
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Creighton University
Study Sponsor Creighton University
Collaborators Not Provided
Investigators
Principal Investigator: Aryan Mooss, MD Creighton University
PRS Account Creighton University
Verification Date September 2011