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

NCT00589849 | Completed Results

• 1 other identifier: 05-13651
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Arrhythmias

Keywords

Myocardial Infarction; Arrhythmia; T-wave alternans

Outcome Measures

Primary Outcomes (2)

• Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI

  30 days

• Event Free Survival at 1 Year

  Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year

  12 months

Study Arms (1)

1

Procedure: T-wave Alternans

Interventions

T-wave Alternans PROCEDURE

T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr. Aryan Mooss
• Organization: Creighton University

aryanmooss@creighton.edu

402-280-4566

Study Officials

• Aryan Mooss, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 10, 2008
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 5, 2011
• Results First Posted: October 5, 2011

Record last verified: 2011-09

Locations

US (1)