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

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ClinicalTrials.gov Identifier: NCT01816399
Recruitment Status : Unknown
Verified March 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2013
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment
Cardiovascular Disease Procedure: Routine coronary angiography

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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Spacial Relation of QRS-T Vectocardiogram is a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG
Study Start Date : April 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Routine coronary angiography patients Procedure: Routine coronary angiography

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing routine coronary angiography

Inclusion Criteria:

  • Patients with normal rest 12-leads ECG

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816399

Contact: Aharon Frimerman, MD 972-523-543264 afrimer@gmail.com

Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01816399     History of Changes
Other Study ID Numbers: HYMC-9-2003b
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

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