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

NCT ID: NCT03253692

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2018-10-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arteriosclerosis Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases

Keywords

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Cardiac Computed Tomography Radiation Iterative Reconstruction Natural History

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus Y Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

Countries

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Canada Germany Israel United Kingdom United States

Related Links

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https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-H-0146.html

NIH Clinical Center Detailed Web Page

Other Identifiers

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17-H-0146

Identifier Type: -

Identifier Source: secondary_id

170146

Identifier Type: -

Identifier Source: org_study_id