AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

China1 site
  • NO.69 Road yongding

    Beijing, Haidian, 100039

Other trials in China

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.

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 groups in NCT01060657
Study groupRoleWhat they receive
conventional (C) groupNot described
low dose (L) groupsNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMay 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT01060657 | AzTrials