Evaluating New Radiation Techniques for Cardiovascular Imaging
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.
Conditions:
🦠 Coronary Disease
🗓️ Study Start (Actual) 21 June 2012
🗓️ Primary Completion (Estimated) 1 April 2025
✅ Study Completion (Estimated) 1 April 2025
👥 Enrollment (Estimated) 5000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 June 2012
  • First Submitted that Met QC Criteria 14 June 2012
  • First Posted 18 June 2012

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified 21 March 2024