Recruiting

Radiation Techniques

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT01621594

Conditions

Coronary Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cannon Aquilion ONE CT system

Study Details

Brief summary:

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging

Background:

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 low dose research imagings are accurate or predict subject outcomes.

Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.

Cardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.

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.
  • Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.

Conditions

Coronary Disease

Study ID

NCT01621594

Start date

Jun 21, 2012

Status verified date

Aug 21, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

5000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 1

Subjects with Clinical indication for a coronary CT angiography exam

Interventions

Cannon 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.

Primary outcome measure

  • 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. [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 31, 2026

Last verified

Aug 21, 2026

Keywords

  • computer tomography
  • Cardiac
  • Radiation Reduction
  • Iterative Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-08-31.