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Evaluating New Radiation Techniques for Cardiovascular Imaging

Primary Purpose

Coronary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Toshiba Aquilion ONE CT system
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Disease focused on measuring computer tomography, Cardiac, Radiation Reduction, Iterative Reconstruction

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Subjects with Clinical indication for a coronary CT angiography exam

Outcomes

Primary Outcome Measures

new imaging methods are accurate or predict subject outcomes.
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.

Secondary Outcome Measures

Estimate radiation dose from clinically performed cardiovascular CT.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Evaluate image quality from new CT technology.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Full Information

First Posted
June 14, 2012
Last Updated
September 30, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01621594
Brief Title
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

2. Study Status

Record Verification Date
September 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2012 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. Participants will have follow-up contact 90 days after the scan, and then yearly contact for the next 5 years.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
computer tomography, Cardiac, Radiation Reduction, Iterative Reconstruction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects with Clinical indication for a coronary CT angiography exam
Intervention Type
Device
Intervention Name(s)
The Toshiba Aquilion ONE CT system
Intervention Description
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 Outcome Measure Information:
Title
new imaging methods are accurate or predict subject outcomes.
Description
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
Secondary Outcome Measure Information:
Title
Estimate radiation dose from clinically performed cardiovascular CT.
Description
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time Frame
ongoing
Title
Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).
Description
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time Frame
ongoing
Title
Evaluate image quality from new CT technology.
Description
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time Frame
ongoing
Title
Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.
Description
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Time Frame
ongoing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret C Lowery, R.N.
Phone
(301) 451-3128
Email
peg.lowery@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Y Chen, M.D.
Phone
(301) 496-0077
Email
chenmy@mail.nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Y Chen, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY dial 711
Email
ccopr@nih.gov

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35389891
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.
Results Reference
derived
PubMed Identifier
27591767
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.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2012-H-0141.html
Description
NIH Clinical Center Detailed Web Page

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Evaluating New Radiation Techniques for Cardiovascular Imaging

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