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T-Wave Alternans (TWA) Reproducibility in CAD Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Assaf-Harofeh Medical Center Identifier:
First received: March 23, 2008
Last updated: March 25, 2008
Last verified: March 2008
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

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

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

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00644345

Contact: Therese Fuchs, MD 972-8-977-9735
Contact: Isaac Zysman, MD 972-8-977-9735

Assaf Harofeh Medical Center Not yet recruiting
Zrifin, Israel
Contact: Therese Fuchs, MD    972-8-977-9735   
Contact: Isaac Zysman, MD    972-8-977-9735   
Principal Investigator: Therese Fuchs, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Therese Fuchs, MD Assaf-Harofeh Medical Center
  More Information

Responsible Party: Therese Fuchs, MD, Assaf Harofeh Medical Center Identifier: NCT00644345     History of Changes
Other Study ID Numbers: 38-08
Study First Received: March 23, 2008
Last Updated: March 25, 2008

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on September 21, 2017