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Clinical Trials/NCT02303067
NCT02303067
Completed
Not Applicable

Prospective International Study of Coronary Subtraction Using 320 Row-Detector CT

National Heart, Lung, and Blood Institute (NHLBI)2 sites in 2 countries13 target enrollmentJanuary 6, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Enrollment
13
Locations
2
Primary Endpoint
Coronary substraction CCTA improves the diagnostic accuracy.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Background:

  • This study is designed for people who need a standard, non-research invasive coronary angiogram to find out if they have heart disease. Researchers want to take a computed tomography (CT) scan of people s hearts before their procedure to see if this less invasive test can also diagnose coronary artery disease.

Objectives:

  • To learn if a new way to view CT pictures is able to accurately diagnose coronary artery disease.

Eligibility:

  • People age 55 and older who need a coronary angiogram.

Design:

  • Participants will be screened with their medical records.
  • Participants may give a blood sample.
  • Participants may have a CT scan of the heart with and without contrast. The CT scan will not interfere with their medical care.
  • Participants blood pressure and heart rhythm will be monitored before, during, and after the CT scan. They may have an electrocardiogram.
  • Before the scan, participants will have an intravenous catheter put into their arm. It will be used to inject contrast.
  • Participants may take a beta blocker to slow their heart rate.
  • Participants may take nitroglycerin under their tongue. It will enlarge their heart blood vessels and improve picture quality. It may cause a flushing sensation or headache.
  • Participants will lie on their back on a padded table. The table slides into a large, donut-shaped machine. An x-ray tube will move around their body, taking pictures. They will be asked to hold their breath for 5 seconds at a time.
  • Participants will be called 30 days after their angiogram. They will answer questions about their health, hospital visits, or medical treatments.

Detailed Description

Coronary calcium can impair the accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction, where areas of calcification identified on a non-contrast scan are removed from the contrast enhanced images. .

Registry
clinicaltrials.gov
Start Date
January 6, 2015
End Date
August 13, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Coronary substraction CCTA improves the diagnostic accuracy.

Time Frame: 3 months

Study Sites (2)

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