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CompletedNCT03253692Updated Aug 17, 2026

Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)

An observational study in Coronary Artery Disease, Coronary Disease and Myocardial Ischemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
66
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Background:

CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure.

Objective:

To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world.

Eligibility:

People ages 18 years and older who need a computed tomography (CT) scan of the heart

Design:

Participants will be screened with a review of their medical records.

Participants may have a pregnancy test.

Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table.

A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.

Read the detailed description

Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to diagnose heart disease; however, it is associated with radiation exposure. Several technological advances in both scanner hardware and software are now available to reduce the radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage of these radiation dose saving strategies in daily practice and analyze their effect on image quality.

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Disease
  • Myocardial Ischemia
  • Arterial Occlusive Diseases
  • Arteriosclerosis

Keywords

  • Cardiac Computed Tomography
  • Radiation
  • Iterative Reconstruction
  • Natural History
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Data confirming the inclusion/exclusion criteria will be confirmed at the study visit. Overall, up to 100 subjects will be enrolled locally at the NIH. A member of the study team will review the CT procedures and confirm that the participants do not have any serious health problems or concomitant conditions or medications that would prevent them from having the CT. A member of the study team will perform a pregnancy test (if applicable) in female participants of childbearing potential. If you are nursing, you will be excluded from this study. All tests will follow NIH Clinical Center policies and clinical consent forms for individual tests may be obtained in addition to the study protocol consent as applicable. Sites outside the NIH will use similar standard of care procedures for cardiac CT eligibility.

Inclusion criteria

  1. Clinical indication for cardiac CT angiography to evaluate coronary arteries or other cardiac structures

    1. Age equal to or greater than 18 years
    2. Able to understand and willing to sign the Informed Consent Form

Exclusion criteria

EXCLUSION CRITERIA:

1) Female participants who are pregnant or nursing

04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
66 participants (actual)

Groups and cohorts

  • Patients

    People ages 18 years and older who need a computed tomography (CT) scan of the heart.

05

What researchers measure

Primary outcomes

  1. Determine radiation dose estimates of cardiac CT angiographies in daily practice

    We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site.

    Time frame: day 0

06

Study locations

3 sites
  • University of Kentucky
    Lexington, Kentucky 40506, United States
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889, United States
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03253692
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Oct 3, 2017
Primary completion
Jun 30, 2018
Completion
Oct 11, 2018
Last update
Aug 17, 2026

Study contacts

Marcus Y Chen, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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