- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632918
Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography (DSCT)
December 25, 2008 updated by: Far Eastern Memorial Hospital
A Retrospective Study of Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography With Regard to Motion Artifact.
The purpose of this study is to investigate the effects of heart rates (including maximum heart rate, average heart rate and minimum heart rate) and variability of heart rate on image quality of DSCT coronary angiography without control of heart rate experienced in our department.
Study Overview
Status
Completed
Conditions
Detailed Description
The dual-source CT (DSCT) equipped with two X-ray tubes at 90 degree offset in the gantry can provide temporal resolution 83ms using mono-segmental reconstruction technique.
The recent studies about the effect of heart rate on IQ of DSCT coronary angiography which concluded in adequate diagnostic IQ of dual-source CTCA without immediate pre-scanning heart rate control included chronic users of β-blocker focused on the influences of average heart rate, heart rate variability and coronary arterial calcifications on IQ.
The effect of blooming artifact of calcification on IQ by far cannot be eliminated.
Here, we investigate the effects of maximum heart rate, average heart rate, minimum heart rate and heart rate variability on the motion-related IQ of DSCT coronary angiography in patients without both pre-scanning heart rate control and chronic use of β-blocker agent, compared with that in chronic users of β-blocker agents.
Study Type
Observational
Enrollment (Actual)
149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taipei
-
Pan-Chiao, Taipei, Taiwan, 200
- Department of Medical Imaing, Far Eastern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patients or examined persons from Taiwan.
Description
Inclusion Criteria:
- From Oct 2006 to Jan 2007, CT coronary angiographies of 180 consecutive adult patients, were performed in our hospital using a DSCT scanner. After exclusion of the patients according to the exclusion criteria, totally DSCT coronary angiographies of 133 adult patients (N=133) were enrolled in this study. Among those 133 patients, including 97 males and 36 females with a mean age of 53.9 (ranging from 21 to 78 year old), 50 patients were chronic β-blocker users (group 1) while the other 83 patients (group 2) were not chronic user of any medication controlling heart rate
Exclusion Criteria:
- The patients below 18 year old, patients with status post heterotopic heart transplantation (having two hearts in a chest), patients with status post coronary by-pass surgery and patients with post indwelling of coronary arterial stents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare the effects of the heart rate variables on motion-related image qualities of DSCT coronary angiography between the group 1 patients of chronic beta-blocker users and the group 2 patients without medication of any heart-rate lowering agent.
Time Frame: About two months
|
About two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kappa Statistics, Descriptive Statistics, Chi-square test, Independent t-test, Pearson's correlation and linear regression method for statistic analysis.
Time Frame: About two to three months
|
About two to three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wing-Keung Cheung, MD, CCD, Far Eastern Memorial Hospital
- Study Chair: Kao-Lun Wang, MD, Far Eastern Memorial Hospital
- Study Chair: Chen-I Yen, BSc, Far Eastern Memorial Hospital
- Study Chair: Shu-Lin Tsen, BSc, Far Eastern Memorial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leschka S, Scheffel H, Desbiolles L, Plass A, Gaemperli O, Valenta I, Husmann L, Flohr TG, Genoni M, Marincek B, Kaufmann PA, Alkadhi H. Image quality and reconstruction intervals of dual-source CT coronary angiography: recommendations for ECG-pulsing windowing. Invest Radiol. 2007 Aug;42(8):543-9. doi: 10.1097/RLI.0b013e31803b93cf.
- Achenbach S, Ropers D, Kuettner A, Flohr T, Ohnesorge B, Bruder H, Theessen H, Karakaya M, Daniel WG, Bautz W, Kalender WA, Anders K. Contrast-enhanced coronary artery visualization by dual-source computed tomography--initial experience. Eur J Radiol. 2006 Mar;57(3):331-5. doi: 10.1016/j.ejrad.2005.12.017. Epub 2006 Jan 19.
- Johnson TR, Nikolaou K, Wintersperger BJ, Leber AW, von Ziegler F, Rist C, Buhmann S, Knez A, Reiser MF, Becker CR. Dual-source CT cardiac imaging: initial experience. Eur Radiol. 2006 Jul;16(7):1409-15. doi: 10.1007/s00330-006-0298-y. Epub 2006 May 13.
- Matt D, Scheffel H, Leschka S, Flohr TG, Marincek B, Kaufmann PA, Alkadhi H. Dual-source CT coronary angiography: image quality, mean heart rate, and heart rate variability. AJR Am J Roentgenol. 2007 Sep;189(3):567-73. doi: 10.2214/AJR.07.2078.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
March 10, 2008
First Posted (Estimate)
March 11, 2008
Study Record Updates
Last Update Posted (Estimate)
December 29, 2008
Last Update Submitted That Met QC Criteria
December 25, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 96064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.