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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00632918
Other study ID # 96064
Secondary ID
Status Completed
Phase N/A
First received March 3, 2008
Last updated December 25, 2008
Start date October 2007
Est. completion date December 2007

Study information

Verified date December 2008
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardTaiwan: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 78 Years
Eligibility 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 ß-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 Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Department of Medical Imaing, Far Eastern Memorial Hospital Pan-Chiao Taipei

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. Epub 2006 Jan 19. — View Citation

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. Epub 2006 May 13. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. About two months Yes
Secondary Kappa Statistics, Descriptive Statistics, Chi-square test, Independent t-test, Pearson's correlation and linear regression method for statistic analysis. About two to three months Yes
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