RecruitingNot ApplicableNCT01621594

Evaluating New Radiation Techniques for Cardiovascular Imaging

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


Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

5,000 participants

Start Date

Jun 21, 2012

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates new lower-radiation techniques for coronary CT angiography — a specialised X-ray scan of the heart's arteries — to ensure they provide high-quality images while minimising radiation exposure to patients. You may be eligible if: - You are 18 years of age or older - You have a clinical reason to have a coronary CT angiography - You are willing and able to provide informed consent and follow-up information You may NOT be eligible if: - You are pregnant - You have severe kidney disease (estimated GFR below 30 mL/min) if contrast dye will be used Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECannon 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(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01621594


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