Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography
March 9, 2015 updated by: Hillel Yaffe Medical Center
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter.
We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
40
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
- Recruiting
- Hillel Yaffe Medical Center
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Contact:
- Aharon Frimerman, MD
- Phone Number: 972-52-3543264
- Email: afrimer@gmail.com
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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 angioplasty
Description
Inclusion Criteria:
- Patients undergoing routine coronary angioplasty
Exclusion Criteria:
- Cardiogenic shock
- Acute myocardial infarction
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy of Co-Registration of IVUS and Coronary Angiography
Time Frame: One month
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For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion.
The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark).
The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm.
The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification.
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One month
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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
March 1, 2015
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
February 16, 2015
First Submitted That Met QC Criteria
February 23, 2015
First Posted (Estimate)
February 27, 2015
Study Record Updates
Last Update Posted (Estimate)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 9, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0028-13-HYMC
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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