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T-Wave Alternans (TWA) Reproducibility in CAD Patients

NCT ID: NCT00644345

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Microvolt T wave alternans reproducibility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh Medical Center

Principal Investigators

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Therese Fuchs, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

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Assaf Harofeh Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Therese Fuchs, MD

Role: CONTACT

Phone: 972-8-977-9735

Email: [email protected]

Isaac Zysman, MD

Role: CONTACT

Phone: 972-8-977-9735

Email: [email protected]

Facility Contacts

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Therese Fuchs, MD

Role: primary

Isaac Zysman, MD

Role: backup

Other Identifiers

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38-08

Identifier Type: -

Identifier Source: org_study_id