New Vectorcardiogram Analysis a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG

March 21, 2013 updated by: Hillel Yaffe Medical Center

Spacial Relation of QRS-T Vectocardiogram is a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG

The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will facilitate the detection of significant coronary disease (CAD) in patients with normal rest 12-leads ECG (NE).

Study Overview

Status

Unknown

Detailed Description

Patients with NE will undergo coronary angiography for routine indications. Prior to the angiography a computerized simultaneous multi-leads ECG will be recorded and, using a new dedicated algorithm for 3D electrical activity reconstruction, the investigators will plot the horizontal VCG of the whole ECG cycle. Using this new VCG analysis we will determine whether the patients have normal coronary arteries or coronary disease.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing routine coronary angiography

Description

Inclusion Criteria:

  • Patients with normal rest 12-leads ECG

Exclusion Criteria:

  • Patients with significant irregular heart beat
  • Patients with heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Routine coronary angiography patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of CAD in patients undergoing routine coronary angiography
Time Frame: One month
Following angiography patients will be categorized as having normal coronary arteries (NC) or coronary disease (CD) if more than 50% lumen diameter narrowing is found in one of the arteries.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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