Clinical trial NCT00632918: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CT
Coronary Angiography
Keywords: Image quality
Dual-source CT
Coronary angiography
Heart rate
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-11
Enrollment: 149
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients or examined persons from Taiwan.

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.

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

Primary outcomes:
measure: 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.
timeFrame: About two months
Secondary outcomes:
measure: Kappa Statistics, Descriptive Statistics, Chi-square test, Independent t-test, Pearson's correlation and linear regression method for statistic analysis.
timeFrame: About two to three months
Other outcomes:
Locations:
city: Pan-Chiao
country: Taiwan
facility: Department of Medical Imaing, Far Eastern Memorial Hospital
state: Taipei
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Wing-Keung Cheung, MD, CCD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern Memorial Hospital
name: Kao-Lun Wang, MD
role: STUDY_CHAIR
affiliation: Far Eastern Memorial Hospital
name: Chen-I Yen, BSc
role: STUDY_CHAIR
affiliation: Far Eastern Memorial Hospital
name: Shu-Lin Tsen, BSc
role: STUDY_CHAIR
References:
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citation: 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.
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. doi: 10.1007/s00330-006-0298-y. Epub 2006 May 13.
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. doi: 10.2214/AJR.07.2078.