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Protocol Details

Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-H-0141

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women

Keywords

computer tomography;
Cardiac;
Radiation Reduction;
Iterative Reconstruction

Recruitment Keyword(s)

None

Condition(s)

Coronary Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: The Toshiba Aquilion ONE CT system

Supporting Site

National Heart, Lung and Blood Institute

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging

Background:

- Imaging studies such as computed tomography (CT) scans involve the use of radiation to create the pictures. Heart and blood vessel CT scans can cause high radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose. Researchers want to see how effective these new methods are in producing accurate CT scans.

Objectives:

- To study new ways of taking pictures of the heart or blood vessels using computed tomography.

Eligibility:

- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.

Design:

- Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function.

- Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours.

- Participants will have follow-up contact 90 days after the scan, and then yearly contact for the next 5 years.

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Eligibility

INCLUSION CRITERIA:

1) Clinical indication for a coronary CT angiography exam

2) Age equal to or greater than 18 years

3) Able to understand and willing to sign the Informed Consent Form

4) Able and willing to provide follow-up information

EXCLUSION CRITERIA:

1) Pregnancy

2) If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the 2021 CK-EPI equation that eliminate the use of race coefficient as reported in CRIS.

Screen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marcus Y. Chen, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM B1D47
10 CENTER DR
BETHESDA MD 20892
(301) 496-0077
chenmy@mail.nih.gov

Margaret C. Lowery, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room B1D416
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3128
peg.lowery@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01621594

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