Evaluating New Radiation Techniques for Cardiovascular Imaging

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01621594
• Other study ID #: 120141
• Secondary ID: 12-H-0141
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2012
• Est. completion date: April 1, 2025

Study information

• Verified date: March 21, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Margaret C Lowery, R.N.
• Phone: (301) 451-3128
• Email: peg.lowery[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• The Toshiba Aquilion ONE CT system
To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new imaging methods are accurate or predict subject outcomes.	Compare time-to-first cardiovascular events (death, revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with >=50% coronary stenosis vs. <50% stenosis.	ongoing
Secondary	Estimate radiation dose from clinically performed cardiovascular CT.	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.	ongoing
Secondary	Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.	ongoing
Secondary	Evaluate image quality from new CT technology.	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.	ongoing
Secondary	Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.	ongoing

External Links

•   NIH Clinical Center Detailed Web Page