Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 25, 2008 |
| Last Updated Date | May 17, 2009 |
| Start Date ICMJE | January 2009 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00815230 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level |
| Official Title ICMJE | Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level |
| 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 | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Retention: None Retained Description: only peripheral blood will be collected for measurement of reactive oxygen species. |
| 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. |
| Condition ICMJE | Radiation Injury |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Estimated Enrollment ICMJE | 20 |
| Estimated Completion Date | March 2009 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 20 Years to 80 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Taiwan |
| Administrative Information | |
| NCT Number ICMJE | NCT00815230 |
| Other Study ID Numbers ICMJE | 200812057R |
| Has Data Monitoring Committee | No |
| Responsible Party | Zei-Shung Huang, associate professor, Department of Internal Medicine, NTUH, National Taiwan University Hospital |
| Study Sponsor ICMJE | National Taiwan University Hospital |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Taiwan University Hospital |
| Verification Date | December 2008 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|