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Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373826
Recruitment Status : Unknown
Verified March 2015 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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.

Condition or disease
Intravascular Ultrasound (IVUS) Angiography Co-registration

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : March 2015
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015



Primary Outcome Measures :
  1. Accuracy of Co-Registration of IVUS and Coronary Angiography [ Time Frame: One month ]
    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.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients undergoing routine coronary angioplasty

Exclusion Criteria:

  • Cardiogenic shock
  • Acute myocardial infarction

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): NCT02373826


Contacts
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Contact: Aharon Frimerman, MD 972-52-3543264 afrimer@gmail.com

Locations
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Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Aharon Frimerman, MD    972-52-3543264    afrimer@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02373826    
Other Study ID Numbers: 0028-13-HYMC
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015