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NCT00006501 · ClinicalTrials.gov registry record

Prognostic Significance of T Wave Alternans

A clinical trial, sponsored by Columbia University.

Completed
Registry status
549
Enrollment target

NCT00006501: Completed study, sponsored by Columbia University.

NCT00006501 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 549 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00006501 has completed, sponsored by Columbia University.

COMPLETED
Registry status
549 participants
Enrollment target

Study Summary

To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac death (SCD) in a prospective epidemiologic natural history study. The prospective epidemiologic pilot study included 550 patients that had left ventricular dysfunction and no history of sustained ventricular arrhythmias. The primary hypothesis tested was whether there was an increased risk of having an arrhythmic event when T Wave Alternans was present in the patient. The secondary aims included comparing risk due to T Wave Alternans between the ischemic patients and non-ischemic patients and assessing whether T Wave Alternans remained an independent predictor of risk upon adjustment for other known risk factors for arrhythmic events such as ejection fraction, ventricular ectopy, NSVT, average NN interval, and RR interval variability. The study approach was a standard epidemiologic surveillance technique. The subject population consisted of individuals with Class I to III heart failure who will underwent a TWA and Holter monitor test and then were followed for up to two years or until arrhythmic events occured.

Interventions

  • PROCEDURE ECG

Trial Details

FieldValue
Enrollment Target 549 participants
Start Date 2003-01
Est. Completion 2012-02
Columbia University

958 total trials

What the finished NCT00006501 record still lists

NCT00006501 is an observational study that tracks outcomes without assigning an intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which ECG is the first listed.

NCT00006501 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00006501 about?

NCT00006501 is a clinical study titled "Prognostic Significance of T Wave Alternans". To evaluate whether T Wave Alternans can predict ventricular arrhythmias and sudden cardiac death (SCD) in a prospective epidemiologic natural history study. The prospective epidemiologic pilot study included 550 patients that had left ventricular dysfunction and no history of sustained ventricular...

What is the current status of trial NCT00006501?

This trial is currently completed. The enrollment target is 549 participants. The study started on 2003-01. Estimated completion is 2012-02.

What interventions are being tested in trial NCT00006501?

The interventions under investigation include: ECG (PROCEDURE).

Who is sponsoring clinical trial NCT00006501?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00006501, the US trial registry maintained by the National Library of Medicine. NCT00006501 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.