NCT00644345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

Enrollment Period

8 months

First QC Date

March 23, 2008

Last Update Submit

March 25, 2008

Conditions

Coronary Artery Disease

Keywords

Microvolt T wave alternansreproducibility

Outcome Measures

Primary Outcomes (1)

  • Reproducibility of TWA test results

    1 week

Secondary Outcomes (1)

  • Ventricular arrhythmias during exercise

    1 week

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease enrolled in a cardiac rehabilitation program.

You may qualify if:

  • Patients enrolled in the cardiac rehabilitation center program
  • Patients with CAD
  • Age \>18 and \< 80 YO
  • Patients with a pacemaker or defibrillator with normal AV conduction

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Therese Fuchs, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Therese Fuchs, MD

CONTACT

972-8-977-9735fuchst@asaf.health.gov.il

Isaac Zysman, MD

CONTACT

972-8-977-9735zysmanI@asaf.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 23, 2008

First Posted

March 26, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

IL(1)