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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00815230
First Posted: December 29, 2008
Last Update Posted: May 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

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.


Condition
Radiation Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   None Retained
only peripheral blood will be collected for measurement of reactive oxygen species.

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: March 2009
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815230


Locations
Taiwan
NTUH
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: Zei-Shung Huang, associate professor, Department of Internal Medicine, NTUH, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00815230     History of Changes
Other Study ID Numbers: 200812057R
First Submitted: December 25, 2008
First Posted: December 29, 2008
Last Update Posted: May 19, 2009
Last Verified: December 2008

Keywords provided by National Taiwan University Hospital:
radiation injury
computed tomography
reactive oxygen species
free radicals

Additional relevant MeSH terms:
Radiation Injuries
Wounds and Injuries