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NCT Number: NCT01621594

Evaluating New Radiation Techniques for Cardiovascular Imaging

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.

Recruiting

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

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 Artificial Intelligence (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:
  • Clinical indication for a coronary CT angiography exam
  • Age equal to or greater than 18 years
  • Able to understand and willing to sign the Informed Consent Form
  • Able and willing to provide follow-up information

Exclusion criteria

  • Pregnancy
  • 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.

Treatment and study plan

Cannon Aquilion ONE CT system

Device

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 outcomes

  1. 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

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Secondary outcomes

  1. Compare and/or validate radiation saving techniques such as iterative reconstruction or artificial intelligence based methods against standard imaging techniques for calcium scoring.

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

  2. Evaluate natural history of coronary plaques in subjects with serial imaging if requested by ordering physician, or in subjects with >50% stenosis or high risk plaques on medical therapy.

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

  3. Estimate diagnostic accuracy of cardiovascular evaluations using current CT technology vs. invasive angiography reports/images and vs. stress perfusion MRI reports/images.

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

  4. Evaluate image quality from new CT technology.

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

  5. Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

  6. Estimate radiation dose from clinically performed cardiovascular CT at the NIH compared to outside clinically indicated CTs.

    Time frame: ongoing

    The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Y Chen, M.D.

CONTACT

[email protected]

(301) 496-0077

Margaret C Lowery, R.N.

CONTACT

[email protected]

(301) 451-3128

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2012
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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