Clinical trial NCT01621594: Evaluating New Radiation Techniques for Cardiovascular Imaging
Official title: Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Disease
Keywords: computer tomography
Cardiac
Radiation Reduction
Iterative Reconstruction
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2012-06-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.
* 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.

Detailed description: 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 new imaging methods are accurate or predict subject outcomes.

Eligibility criteria: * 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.

Primary outcomes:
measure: new imaging methods are accurate or predict subject outcomes.
timeFrame: ongoing
Secondary outcomes:
measure: Estimate radiation dose from clinically performed cardiovascular CT.
timeFrame: ongoing
measure: Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).
timeFrame: ongoing
measure: Evaluate image quality from new CT technology.
timeFrame: ongoing
measure: Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.
timeFrame: ongoing
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Marcus Y Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorokin AV, Patel N, Abdelrahman KM, Ling C, Reimund M, Graziano G, Sampson M, Playford MP, Dey AK, Reddy A, Teague HL, Stagliano M, Amar M, Chen MY, Mehta NN, Remaley AT. Complex association of apolipoprotein E-containing HDL with coronary artery disease burden in cardiovascular disease. JCI Insight. 2022 May 23;7(10):e159577. doi: 10.1172/jci.insight.159577.
citation: Choi AD, Leifer ES, Yu J, Shanbhag SM, Bronson K, Arai AE, Chen MY. Prospective evaluation of the influence of iterative reconstruction on the reproducibility of coronary calcium quantification in reduced radiation dose 320 detector row CT. J Cardiovasc Comput Tomogr. 2016 Sep-Oct;10(5):359-63. doi: 10.1016/j.jcct.2016.07.016. Epub 2016 Jul 27.