- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816399
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
Conditions
Intervention / Treatment
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
-
-
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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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
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYMC-9-2003b
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.