Mechanical Alternans Study (MAS)

April 6, 2015 updated by: Larisa Tereshchenko, Johns Hopkins University

Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with structural heart disease, ischemic or non-ischemic cardiomyopahty

Description

Inclusion Criteria:

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

  • pregnancy
  • age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sudden arrhythmic death
Time Frame: 5 years
appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular mortality
Time Frame: 5 years
5 years
all-cause death
Time Frame: 5 years
5 years
appropriate ICD therapies
Time Frame: 5 years
either ICD shock or antitachycardia pacing due to ventricular arrhythmia
5 years
composite heart failure endpoint
Time Frame: 5 years
pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00032758

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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