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Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography (DSCT)
This study has been completed.
First Received: March 3, 2008   Last Updated: December 25, 2008   History of Changes
Sponsored by: Far Eastern Memorial Hospital
Information provided by: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00632918
  Purpose

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.


Condition
CT
Coronary Angiography

Study Type: Observational
Study Design: Case-Only, Retrospective
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.

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

No biospecimens


Enrollment: 149
Study Start Date: October 2007
Study Completion Date: December 2007
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

Ages Eligible for Study:   21 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The patients or examined persons from Taiwan.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632918

Locations
Taiwan, Taipei
Department of Medical Imaing, Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan, 200
Sponsors and Collaborators
Far Eastern Memorial Hospital
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
  More Information

Publications:
Responsible Party: Department of Medical Imaging in Far Eastern Memorial Hospital ( Wing-Keung Cheung M.D. / Visiting Staff of Department of Medical Imaging in Far Easten Memorial Hospital )
Study ID Numbers: 96064
Study First Received: March 3, 2008
Last Updated: December 25, 2008
ClinicalTrials.gov Identifier: NCT00632918     History of Changes
Health Authority: United States: Institutional Review Board;   Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
Image quality
Dual-source CT
Coronary angiography
Heart rate

ClinicalTrials.gov processed this record on September 10, 2009