T-Wave Alternans (TWA) Reproducibility in CAD Patients

Coronary Artery Disease Clinical Trial

Official title:

Reproducibility of T Wave Alternans Testing in Patients With Ischemic Heart Disease.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00644345
• Other study ID #: 38-08
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2008
• Last updated: March 25, 2008
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2008
• Source: Assaf-Harofeh Medical Center
• Contact: Therese Fuchs, MD
• Phone: 972-8-977-9735
• Email: fuchst[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of TWA test results		1 week	No
Secondary	Ventricular arrhythmias during exercise		1 week	No