T-Wave Alternans (TWA) Reproducibility in CAD Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00644345
First received: March 23, 2008
Last updated: March 25, 2008
Last verified: March 2008
  Purpose

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
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.

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

Primary Outcome Measures:
  • Reproducibility of TWA test results [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventricular arrhythmias during exercise [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014