Coronary Artery DiseaseNCT01060657
Clinical Values of Dose Reduction Techniques in Computed Tomography (CT) Coronary Artery Imaging With 64-row Multi-Slice Helical CT
An observational study of Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT coronary artery imaging. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Dec 2011
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Five hundred patients will be recruited over one and half years from our institution and other hospitals for suspected coronary artery disease. All patients will give informed consent and our Institutional Review Board approved the study.
Who may be able to join
- body height and weight of 160 cm to 175 cm, and 55 kg to 75 kg, respectively.
Who cannot join
- with acute heart failure, severe arrhythmia and severe renal dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT coronary artery imaging.
Read the detailed description
Five hundred patients will be recruited over one and half years from our institution and other hospitals for suspected coronary artery disease. All patients will give informed consent and our Institutional Review Board approved the study. To obtain relatively consistent image noise, patients will be limited to body height and weight of 160 cm to 175 cm,and 55 kg to 75 kg, respectively. Patients with acute heart failure, severe arrhythmia and severe renal dysfunction will be excluded from the cardiac studies.
All patients underwent CT coronary artery scans using a 64-row multi-detector CT (MDCT) scanner (Light Speed VCT, GE Healthcare)in supine position. The five hundred patients were divided into conventional (C)and low dose (L) scan groups with 250 patients in each group. The patient distributions in terms of height, weight, body mass index (BMI)and heart rate were similar for the two groups with no statistically significant difference. Patients will be given bocker of about 25-50 mg orally when necessary one-hour before the cardiac scans to control heart rates and reduce their variations. Patient heart rates during CT scans were 43 to 81. A single scout scan shall be performed on every patient to cover the whole heart area, which is about 12cm. CT calcification scoring scan was performed for every patient before the CT angiography (CTA) according to the standard protocols at our institution. Timing bolus scans were performed before CTA to determine the scan start delay time: A total of 15 ml contrast agent was injected intravenously. Cine scans were used to monitor the contrast enhancement in the aorta. An ROI was placed on the ascending aorta and contrast enhancement curve as function of time was measured to determine the blood circulation time between vein of the elbow and aorta. This time was then used to determine the optimal scan delay time for CTA. The retrospective ECG-gated helical CTA scan will be then performed with predetermined scan delay time and with minimum scan range to just cover the whole heart. 70 ml contrast agent will be injected at 4.5 ml/s injection rate intravenously followed by 30ml of saline at the same injection rate.Standard scan technique shall be used for the CTA scans for the C group including: 120kV,640mA,0.35s rotation speed, 0.625 mm slice thickness, body bowtie, and 0.20-0.26 pitch selected automatically by the scanner based on the patient heart rates. For patients in L group combinations of dose reduction techniques will be applied including the use of application-specific cardiac bowtie,and adaptive post-processing filter C2,and ECG mA modulation with full tube current of 450mA for cardiac phases of 40-80%and 90mA for the rest of the cardiac phases. Cardiac bowtie provides more x-rays near the center and less x-rays towards the edge compared to a typical body bowtie to optimize x-ray distribution for cardiac applications. Our previous studies have demonstrated its advantages of image noise reduction for the heart as well as overall dose (CTDI)reduction. The lower tube current selection for the patients in L group shall be based on previous studies which indicated that the noise reduction advantage of the adaptive post-processing filter C2 might be converted into the use of lower mA to achieve similar image noise as with higher mA in clinical applications.
All images will be reconstructed with standard segment reconstruction algorithm. For the L group with lower tube current, we will apply the adaptive post-processing filter C2 to reduce image noise. Two experienced radiologists quantitatively evaluated the image quality blindly in terms of the number of coronary arteries and smaller branches identified, the sharpness of vessel edges and contrast agent clarity in the vessels using scores of 1-4 with 4 being the highest. Score 4 would indicate that at least 13 coronary artery segments could be identified,and up to the 3rd branch. Also, all identified vessels have sharp edge and clear delineations of contrast agent in the vessels. If any one of the above parameters is not satisfactory, then the quality score would be 3 and 2 if any two parameters are not as good. Image noises will be measured for the two sets with ROI placed at the center of the ascending aorta in the same place for both groups. CTDI values will be recorded for each group and converted into effective dose (ED) using European DLP method. We shall perform statistical analyses on the quality scores,the noise measurements and the effective dose measurements from the two sets using t-test with the spss10.0 software.
- Conditions
- Coronary Artery Disease
- Keywords
- X-ray Computed Tomography, Coronary vessels, Radiation dosage
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conventional (C) group | Not described | |
| low dose (L) groups | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Collaborators
- 181 Central Hospital of the Chinese PLA, Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060657
- Sponsor's protocol ID
- wgs1996
- Status last verified
- Jan 2010
- First submitted
- 31 Jan 2010
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bischoff B, Hein F, Meyer T, Hadamitzky M, Martinoff S, Schomig A, Hausleiter J. Impact of a reduced tube voltage on CT angiography and radiation dose: results of the PROTECTION I study. JACC Cardiovasc Imaging. 2009 Aug;2(8):940-6. doi: 10.1016/j.jcmg.2009.02.015.
PubMed 19679281
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Values of Dose Reduction Techniques in Computed Tomography (CT) Coronary Artery Imaging With 64-row Multi-Slice Helical CT
- ClinicalTrials.gov ID
- NCT01060657
- Acronym / sponsor ID
- wgs1996
- Conditions
- Coronary Artery Disease
- Keywords
- X-ray Computed Tomography, Coronary vessels, Radiation dosage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Collaborators
- 181 Central Hospital of the Chinese PLA, Ningxia Medical University
- Study start
- Dec 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Feb 2010 (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.
To evaluate the clinical values of using dose reduction techniques in 64-row multi-slice CT coronary artery imaging.
Detailed description
Five hundred patients will be recruited over one and half years from our institution and other hospitals for suspected coronary artery disease. All patients will give informed consent and our Institutional Review Board approved the study. To obtain relatively consistent image noise, patients will be limited to body height and weight of 160 cm to 175 cm,and 55 kg to 75 kg, respectively. Patients with acute heart failure, severe arrhythmia and severe renal dysfunction will be excluded from the cardiac studies.
All patients underwent CT coronary artery scans using a 64-row multi-detector CT (MDCT) scanner (Light Speed VCT, GE Healthcare)in supine position. The five hundred patients were divided into conventional (C)and low dose (L) scan groups with 250 patients in each group. The patient distributions in terms of height, weight, body mass index (BMI)and heart rate were similar for the two groups with no statistically significant difference. Patients will be given bocker of about 25-50 mg orally when necessary one-hour before the cardiac scans to control heart rates and reduce their variations. Patient heart rates during CT scans were 43 to 81. A single scout scan shall be performed on every patient to cover the whole heart area, which is about 12cm. CT calcification scoring scan was performed for every patient before the CT angiography (CTA) according to the standard protocols at our institution. Timing bolus scans were performed before CTA to determine the scan start delay time: A total of 15 ml contrast agent was injected intravenously. Cine scans were used to monitor the contrast enhancement in the aorta. An ROI was placed on the ascending aorta and contrast enhancement curve as function of time was measured to determine the blood circulation time between vein of the elbow and aorta. This time was then used to determine the optimal scan delay time for CTA. The retrospective ECG-gated helical CTA scan will be then performed with predetermined scan delay time and with minimum scan range to just cover the whole heart. 70 ml contrast agent will be injected at 4.5 ml/s injection rate intravenously followed by 30ml of saline at the same injection rate.Standard scan technique shall be used for the CTA scans for the C group including: 120kV,640mA,0.35s rotation speed, 0.625 mm slice thickness, body bowtie, and 0.20-0.26 pitch selected automatically by the scanner based on the patient heart rates. For patients in L group combinations of dose reduction techniques will be applied including the use of application-specific cardiac bowtie,and adaptive post-processing filter C2,and ECG mA modulation with full tube current of 450mA for cardiac phases of 40-80%and 90mA for the rest of the cardiac phases. Cardiac bowtie provides more x-rays near the center and less x-rays towards the edge compared to a typical body bowtie to optimize x-ray distribution for cardiac applications. Our previous studies have demonstrated its advantages of image noise reduction for the heart as well as overall dose (CTDI)reduction. The lower tube current selection for the patients in L group shall be based on previous studies which indicated that the noise reduction advantage of the adaptive post-processing filter C2 might be converted into the use of lower mA to achieve similar image noise as with higher mA in clinical applications.
All images will be reconstructed with standard segment reconstruction algorithm. For the L group with lower tube current, we will apply the adaptive post-processing filter C2 to reduce image noise. Two experienced radiologists quantitatively evaluated the image quality blindly in terms of the number of coronary arteries and smaller branches identified, the sharpness of vessel edges and contrast agent clarity in the vessels using scores of 1-4 with 4 being the highest. Score 4 would indicate that at least 13 coronary artery segments could be identified,and up to the 3rd branch. Also, all identified vessels have sharp edge and clear delineations of contrast agent in the vessels. If any one of the above parameters is not satisfactory, then the quality score would be 3 and 2 if any two parameters are not as good. Image noises will be measured for the two sets with ROI placed at the center of the ascending aorta in the same place for both groups. CTDI values will be recorded for each group and converted into effective dose (ED) using European DLP method. We shall perform statistical analyses on the quality scores,the noise measurements and the effective dose measurements from the two sets using t-test with the spss10.0 software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional (C) group | – | – |
| low dose (L) groups | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Five hundred patients will be recruited over one and half years from our institution and other hospitals for suspected coronary artery disease. All patients will give informed consent and our Institutional Review Board approved the study.
Key inclusion criteria (1 listed)
- body height and weight of 160 cm to 175 cm, and 55 kg to 75 kg, respectively.
Key exclusion criteria (1 listed)
- with acute heart failure, severe arrhythmia and severe renal dysfunction.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Background: PubMed 19679281Bischoff B, Hein F, Meyer T, Hadamitzky M, Martinoff S, Schomig A, Hausleiter J. Impact of a reduced tube voltage on CT angiography and radiation dose: results of the PROTECTION I study. JACC Cardiovasc Imaging. 2009 Aug;2(8):940-6. doi: 10.1016/j.jcmg.2009.02.015.
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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 Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 2 Feb 2010. 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 China. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT01060657, which also lists 1 linked publication.
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 2 Feb 2010.