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Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography (DSCT)

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ClinicalTrials.gov Identifier: NCT00632918
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : December 29, 2008
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Tracking Information
First Submitted Date March 3, 2008
First Posted Date March 11, 2008
Last Update Posted Date December 29, 2008
Study Start Date October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 25, 2008)
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 ]
Original Primary Outcome Measures
 (submitted: March 10, 2008)
Image quality scores observed from reconstructed images of DSCT coronary angiography, reconstruction windows of of ECG for coronary arteries and the heart rates and variability of heart rates of each patient recorded prior to and during scanning. [ Time Frame: About one month ]
Change History
Current Secondary Outcome Measures
 (submitted: December 25, 2008)
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 ]
Original Secondary Outcome Measures
 (submitted: March 10, 2008)
Kappa Statistics, Descriptive Statistics, Pearson's correlation and linear regression method for statistic analysis. [ Time Frame: About two to three months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography
Official Title 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.
Brief Summary 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No biospecimens
Sampling Method Probability Sample
Study Population The patients or examined persons from Taiwan.
Condition
  • CT
  • Coronary Angiography
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2008)
149
Original Actual Enrollment Same as current
Actual Study Completion Date December 2007
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00632918
Other Study ID Numbers 96064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wing-Keung Cheung M.D. / Visiting Staff of Department of Medical Imaging in Far Easten Memorial Hospital, Department of Medical Imaging in Far Eastern Memorial Hospital
Study Sponsor Far Eastern Memorial Hospital
Collaborators Not Provided
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
PRS Account Far Eastern Memorial Hospital
Verification Date December 2008