Prospective International Study of Coronary Subtraction Using 320 Detector

Status Completed

Clinical Trial 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.

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02303067
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase
Start date	January 6, 2015
Completion date	August 13, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms