Radiation InjuryNCT00815230
Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
An observational study of Radiation Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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]. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Injury
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease.
Who may be able to join
- subjects who are arranged for cardiac CTA examination because of suspect coronary artery disease.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Radiation Injury
- Keywords
- radiation injury, computed tomography, reactive oxygen species, free radicals
- Medical subject headings
- Radiation Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startJan 2009
- Study completionMar 2009 (estimated)
Why it stopped: because of unexpected administrative barrier, it was very difficult to enroll case.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815230
- Sponsor's protocol ID
- 200812057R
- Status last verified
- Dec 2008
- First submitted
- 25 Dec 2008
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
- ClinicalTrials.gov ID
- NCT00815230
- Acronym / sponsor ID
- 200812057R
- Conditions
- Radiation Injury
- Keywords
- radiation injury, computed tomography, reactive oxygen species, free radicals
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: because of unexpected administrative barrier, it was very difficult to enroll case.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Study completion
- Mar 2009 (estimated)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease.
Key inclusion criteria (1 listed)
- subjects who are arranged for cardiac CTA examination because of suspect coronary artery disease.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009.