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Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level

This study has been withdrawn prior to enrollment.
(because of unexpected administrative barrier, it was very difficult to enroll case.)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00815230
First received: December 25, 2008
Last updated: May 17, 2009
Last verified: December 2008

December 25, 2008
May 17, 2009
January 2009
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Complete list of historical versions of study NCT00815230 on ClinicalTrials.gov Archive Site
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Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level

The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the cardiac computed tomography angiography (cardiac CTA) may induce a higher level of ROS in the peripheral blood.

Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease (CAD). In total, twenty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families after the arrangement of cardiac CTA. It then will be retrieved just before the performance of cardiac CTA.

For each enrolled case, peripheral blood will be sampled three times (once before and twice after the performance of cardiac CTA). Totally 60 blood samples will be collected from 20 study subjects within 3 months (January 1 ~ March 31, 2009). ROS level in the collected blood samples will be then measured, compared, and analyzed.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   None Retained
Description:

only peripheral blood will be collected for measurement of reactive oxygen species.

Non-Probability Sample

Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease.

Radiation Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
March 2009
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Inclusion Criteria:

  • subjects who are arranged for cardiac CTA examination because of suspect coronary artery disease.

Exclusion Criteria:

  • none
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00815230
200812057R
No
Zei-Shung Huang, associate professor, Department of Internal Medicine, NTUH, National Taiwan University Hospital
National Taiwan University Hospital
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National Taiwan University Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP