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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• 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.

Description

• INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

1) Female participants who are pregnant or nursing

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; People ages 18 years and older who need a computed tomography (CT) scan of the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 0

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marcus Y Chen, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 6, 2026

More Information

Terms related to this study

• Keywords: Natural History; Radiation; Cardiac Computed Tomography; Iterative Reconstruction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: 170146; 17-H-0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No