Viewing Study NCT00815230



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Study NCT ID: NCT00815230
Status: WITHDRAWN
Last Update Posted: 2009-05-19
First Post: 2008-12-25

Brief Title: Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
Status: WITHDRAWN
Status Verified Date: 2008-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: because of unexpected administrative barrier it was very difficult to enroll case
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None