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NCT01816399 Clinical Trial

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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01816399
Other study ID # HYMC-9-2003b
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2013
Last updated March 21, 2013
Start date April 2013
Est. completion date June 2013

Study information
Verified date March 2013
Source Hillel Yaffe Medical Center
Contact Aharon Frimerman, MD
Phone 972-523-543264
Email afrimer@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with normal rest 12-leads ECG

Exclusion Criteria:

- Patients with significant irregular heart beat

- Patients with heart failure

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Routine coronary angiography

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of CAD in patients undergoing routine coronary angiography 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 No
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