Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-03 @ 2:52 AM
Study NCT ID:
NCT02219594
Status:
UNKNOWN
Last Update Posted:
2014-08-19
First Post:
2014-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2014-08-10', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of the physical characteristics of in-stent restenosis structures seen on OCT', 'timeFrame': 'On the day in which a patient receives the check of OCT'}], 'primaryOutcomes': [{'measure': 'Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated', 'timeFrame': 'On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins', 'description': 'Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.'}], 'secondaryOutcomes': [{'measure': 'Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT', 'timeFrame': 'one month', 'description': 'In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gemstone CT', '320-detector row spiral CT', 'optical coherence tomography(OCT)', 'in-stent restenosis', 'coronary heart disease'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '19000485', 'type': 'BACKGROUND', 'citation': 'Colombo A, Latib A. [Treatment of drug-eluting stent restenosis with another drug-eluting stent: do not fail the second time!]. Rev Esp Cardiol. 2008 Nov;61(11):1120-2. No abstract available. Spanish.'}, {'pmid': '18765162', 'type': 'BACKGROUND', 'citation': 'Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.'}, {'pmid': '10898406', 'type': 'BACKGROUND', 'citation': 'Pasterkamp G, Falk E, Woutman H, Borst C. Techniques characterizing the coronary atherosclerotic plaque: influence on clinical decision making? J Am Coll Cardiol. 2000 Jul;36(1):13-21. doi: 10.1016/s0735-1097(00)00677-x.'}, {'pmid': '15636110', 'type': 'BACKGROUND', 'citation': 'Chau AH, Chan RC, Shishkov M, MacNeill B, Iftimia N, Tearney GJ, Kamm RD, Bouma BE, Kaazempur-Mofrad MR. Mechanical analysis of atherosclerotic plaques based on optical coherence tomography. Ann Biomed Eng. 2004 Nov;32(11):1494-503. doi: 10.1114/b:abme.0000049034.75368.4a.'}, {'pmid': '19704093', 'type': 'BACKGROUND', 'citation': 'Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.'}, {'pmid': '17354629', 'type': 'RESULT', 'citation': 'Manfrini O, Slucca M, Bugiardini R. [Optical coherence tomography]. G Ital Cardiol (Rome). 2007 Jan;8(1):28-33. Italian.'}, {'type': 'RESULT', 'citation': 'Andreini D，Pontone G，Mushtaq S，et a1．Multidetector computed tomography coronary angiography for the assessment of coronary in-stent restenosis．Am J Cardiol，2010,105:645.'}]}, 'descriptionModule': {'briefSummary': 'In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis.\n\nThe improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement\'s accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.\n\nThis study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 20-80， All genders\n2. Unlimited time of implantation of coronary artery stents\n3. Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation\n4. No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests\n5. Routine re-testing 9-12 months after stent implantation.\n\nExclusion Criteria:\n\n1. Renal insufficiency (serum creatinine \\> 120 umol/L)\n2. Allergy of contrast\n3. Severe heart failure\n4. Uncontrollable heart rate or contraindication of taking metoprolol\n5. Unstable condition\n6. the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.'}, 'identificationModule': {'nctId': 'NCT02219594', 'briefTitle': 'The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent', 'organization': {'class': 'OTHER', 'fullName': 'Xuzhou Central Hospital'}, 'officialTitle': 'The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent', 'orgStudyIdInfo': {'id': 'W201310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemstone CT', 'description': 'Gemstone CT ：Discovery CT750 HD（high definition） ，GE（General Electric Co.） Healthcare, Milwaukee； CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient', 'interventionNames': ['Device: CT image for patient with suspected in-stent restenosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '320-detector row spiral CT', 'description': '320-detector row spiral CT：Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .', 'interventionNames': ['Device: CT image for patient with suspected in-stent restenosis']}], 'interventions': [{'name': 'CT image for patient with suspected in-stent restenosis', 'type': 'DEVICE', 'otherNames': ['Gemstone CT', '320-detector row spiral CT', 'OCT'], 'description': 'Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.', 'armGroupLabels': ['320-detector row spiral CT', 'Gemstone CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng chunguang, PhD', 'role': 'CONTACT', 'email': 'fcg999@163.com', 'phone': '+8618936376559'}, {'name': 'Feng chunguang, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xuzhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Feng chunguang, PhD', 'role': 'CONTACT', 'email': 'fcg999@163.com', 'phone': '+8618936376559'}], 'overallOfficials': [{'name': 'Institute of Cardiovascular Disease Xuzhou Central Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Southeast University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}