Clinical trial NCT03253692: Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)
Official title: Prospective Multicenter Registry On Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Keywords: Cardiac Computed Tomography
Radiation
Iterative Reconstruction
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-08-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Determine radiation dose estimates of cardiac CT angiographies in daily practice
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Marcus Y Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: