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

NCT03253692 | Completed

• 2 other identifiers: 17014617-H-0146
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

Cardiac Computed Tomography; Radiation; Iterative Reconstruction; Natural History

Outcome Measures

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.

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Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical indication for cardiac CT angiography to evaluate coronary arteries or other cardiac structures
• Age equal to or greater than 18 years
• Able to understand and willing to sign the Informed Consent Form

You may not qualify if:

• \) Female participants who are pregnant or nursing

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (3)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Marcus Y Chen, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 18, 2017
• Study Start: October 3, 2017
• Primary Completion: June 30, 2018
• Study Completion: October 11, 2018
• Last Updated: April 8, 2026

Record last verified: 2026-04-06

Locations

US (3)