Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00632918
Status:
COMPLETED
Last Update Posted:
2008-12-29
First Post:
2008-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-25', 'studyFirstSubmitDate': '2008-03-03', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2008-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Image quality', 'Dual-source CT', 'Coronary angiography', 'Heart rate'], 'conditions': ['CT', 'Coronary Angiography']}, 'referencesModule': {'references': [{'pmid': '17620936', 'type': 'BACKGROUND', '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. doi: 10.1097/RLI.0b013e31803b93cf.'}, {'pmid': '16426789', 'type': 'BACKGROUND', '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.'}, {'pmid': '16770652', 'type': 'RESULT', '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.'}, {'pmid': '17715102', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients or examined persons from Taiwan.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT00632918', 'acronym': 'DSCT', 'briefTitle': 'Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '96064'}}, 'contactsLocationsModule': {'locations': [{'zip': '200', 'city': 'Banqiao District', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Medical Imaing, Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'overallOfficials': [{'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', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wing-Keung Cheung M.D. / Visiting Staff of Department of Medical Imaging in Far Easten Memorial Hospital', 'oldOrganization': 'Department of Medical Imaging in Far Eastern Memorial Hospital'}}}}