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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Completed

CT.gov ID

NCT03253692

Collaborator

(none)

Enrollment

Location

12.3

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis

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 Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 3, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Oct 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients People ages 18 years and older who need a computed tomography (CT) scan of the heart.

Outcome Measures

Primary Outcome Measures

Determine radiation dose estimates of cardiac CT angiographies in daily practice [day 0]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

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