Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 55 - 99 |
| Updated: | 3/27/2019 |
| Start Date: | January 6, 2015 |
| End Date: | August 13, 2018 |
Prospective International Study of Coronary Subtraction Using 320 Row-Detector CT
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.
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.
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.
- INCLUSION CRITERIA:
1. Age over 55 years
2. Subjects referred for coronary angiography
3. Able to understand and willing to sign the Informed Consent Form
EXCLUSION CRITERIA:
1. Known allergy to iodinated contrast media
2. Estimated GFR less than 50 ml/min
3. Atrial fibrillation or other continuous cardiac arrhythmias
4. Known or suspected intolerance or contraindication to beta-blocker medication (i.e.
significant reactive airway disease, decompensated heart failure, Mobitz type 2 second
degree or 3rd degree atrio-ventricular heart block)
5. Inability to adequately hold breath for 5 seconds
6. Pregnancy. Women of child bearing potential must demonstrate a negative pregnancy test
within 24 hours of the study MDCT.
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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