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T-Wave Alternans (TWA) Reproducibility in CAD Patients

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ClinicalTrials.gov Identifier: NCT00644345
Recruitment Status : Unknown
Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2008
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.

Condition or disease
Coronary Artery Disease

Detailed Description:

The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll.

Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.


Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.
Study Start Date : May 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Reproducibility of TWA test results [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Ventricular arrhythmias during exercise [ Time Frame: 1 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease enrolled in a cardiac rehabilitation program.
Criteria

Inclusion Criteria:

  1. Patients enrolled in the cardiac rehabilitation center program
  2. Patients with CAD
  3. Age >18 and < 80 YO
  4. Patients with a pacemaker or defibrillator with normal AV conduction

Exclusion Criteria:

  1. Patients with chronic AF
  2. Patients with multiple APB's or PVC's
  3. Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker.
  4. Patients who are unable to exercise on a bicycle.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644345


Contacts
Contact: Therese Fuchs, MD 972-8-977-9735 fuchst@asaf.health.gov.il
Contact: Isaac Zysman, MD 972-8-977-9735 zysmanI@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zrifin, Israel
Contact: Therese Fuchs, MD    972-8-977-9735    fuchst@asaf.health.gov.il   
Contact: Isaac Zysman, MD    972-8-977-9735    zysmanI@asaf.health.gov.il   
Principal Investigator: Therese Fuchs, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Therese Fuchs, MD Assaf-Harofeh Medical Center
More Information

Responsible Party: Therese Fuchs, MD, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00644345     History of Changes
Other Study ID Numbers: 38-08
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008

Keywords provided by Assaf-Harofeh Medical Center:
Microvolt T wave alternans
reproducibility

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases