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

NCT ID: NCT00589849

Last Updated: 2011-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Myocardial Infarction Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

T-wave Alternans

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aryan Mooss, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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05-13651

Identifier Type: -

Identifier Source: secondary_id

05-13651

Identifier Type: -

Identifier Source: org_study_id