Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT01083134
Status:
UNKNOWN
Last Update Posted:
2014-07-29
First Post:
2010-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-28', 'studyFirstSubmitDate': '2010-03-07', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAD'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'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': '17075011', 'type': 'BACKGROUND', 'citation': 'Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation. 2006 Nov 21;114(21):2251-60. doi: 10.1161/CIRCULATIONAHA.106.634808. Epub 2006 Oct 30.'}, {'pmid': '17179348', 'type': 'BACKGROUND', 'citation': 'Johnson TR, Nikolaou K, Wintersperger BJ, Knez A, Boekstegers P, Reiser MF, Becker CR. ECG-gated 64-MDCT angiography in the differential diagnosis of acute chest pain. AJR Am J Roentgenol. 2007 Jan;188(1):76-82. doi: 10.2214/AJR.05.1153.'}, {'pmid': '17031451', 'type': 'BACKGROUND', 'citation': 'Scheffel H, Alkadhi H, Plass A, Vachenauer R, Desbiolles L, Gaemperli O, Schepis T, Frauenfelder T, Schertler T, Husmann L, Grunenfelder J, Genoni M, Kaufmann PA, Marincek B, Leschka S. Accuracy of dual-source CT coronary angiography: First experience in a high pre-test probability population without heart rate control. Eur Radiol. 2006 Dec;16(12):2739-47. doi: 10.1007/s00330-006-0474-0. Epub 2006 Sep 19.'}, {'pmid': '19011135', 'type': 'BACKGROUND', 'citation': 'Einstein AJ. Radiation risk from coronary artery disease imaging: how do different diagnostic tests compare? Heart. 2008 Dec;94(12):1519-21. doi: 10.1136/hrt.2007.135731. No abstract available.'}, {'pmid': '16520411', 'type': 'BACKGROUND', 'citation': 'Hausleiter J, Meyer T, Hadamitzky M, Huber E, Zankl M, Martinoff S, Kastrati A, Schomig A. Radiation dose estimates from cardiac multislice computed tomography in daily practice: impact of different scanning protocols on effective dose estimates. Circulation. 2006 Mar 14;113(10):1305-10. doi: 10.1161/CIRCULATIONAHA.105.602490. Epub 2006 Mar 6.'}, {'pmid': '15151967', 'type': 'BACKGROUND', 'citation': 'Yates SJ, Pike LC, Goldstone KE. Effect of multislice scanners on patient dose from routine CT examinations in East Anglia. Br J Radiol. 2004 Jun;77(918):472-8. doi: 10.1259/bjr/21927258.'}, {'pmid': '19137311', 'type': 'BACKGROUND', 'citation': 'Hein PA, Romano VC, Lembcke A, May J, Rogalla P. Initial experience with a chest pain protocol using 320-slice volume MDCT. Eur Radiol. 2009 May;19(5):1148-55. doi: 10.1007/s00330-008-1255-8. Epub 2009 Jan 10.'}, {'pmid': '11368702', 'type': 'BACKGROUND', 'citation': 'Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.'}, {'pmid': '440357', 'type': 'BACKGROUND', 'citation': 'Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. doi: 10.1056/NEJM197906143002402.'}]}, 'descriptionModule': {'briefSummary': 'With the advances in multidetector computed tomography (MDCT) technology, CT angiography (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD). Reported sensitivities and specificities of coronary CTA can compete with those of catheter angiography.\n\nBecause CT is the major source of ionizing radiation in medicine, dual isotope myocardial perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated with the highest amount of radiation dose. Recently, a new generation of MDCT machines with even more detector row (320) has become clinically available. The maximum detector width of 16 cm enables the entire heart to be examined in a single rotation and within a single heartbeat and is expected to substantially reduce artifacts from breathing and body motion. Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated examination of the heart within a single breath-hold.\n\nThe purpose of this study was to investigate the correlation of hemodynamic status of 320 MDCT, echocardiography, and coronary catheterization in patients who suspected coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'According to Diamond and Forrester colleague, there are risks including age, gender, smoking, diabetes, and dyslipidemia for coronary artery disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intermediate or high risk for coronary artery disease\n2. Healthy volunteers\n\nExclusion Criteria:\n\n1. Unstable angina\n2. Acute myocardial infarction\n3. Active cancer status\n4. Renal failure(Creatinine \\> 1.5 mg/dl)\n5. Contrast allergy history\n6. Pregnancy'}, 'identificationModule': {'nctId': 'NCT01083134', 'briefTitle': 'The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'orgStudyIdInfo': {'id': '98-4077B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'percentage of stenosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tsang-Tang Hsieh, MD', 'role': 'CONTACT', 'email': 'tth3388@adm.cgmh.org.tw', 'phone': '+886 -3-3196200', 'phoneExt': '3656'}, {'name': 'Cheng Hung Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cheng Gung Memorial Hospital at Linkou', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}