Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-01 @ 10:25 AM
Study NCT ID:
NCT02303067
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Prospective International Study of Coronary Subtraction Using 320 Row-Detector CT
Status:
COMPLETED
Status Verified Date:
2018-08-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
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Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15-H-0026 | None | None | View |