Evaluating New Radiation Techniques for Cardiovascular Imaging

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT01621594
Status
Recruiting
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Conditions

  • Coronary Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 21, 2012
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
5,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 1
    Subjects with Clinical indication for a coronary CT angiography exam

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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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