Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 6:17 AM
Study NCT ID:
NCT00431860
Status:
UNKNOWN
Last Update Posted:
2007-05-03
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-05-02', 'studyFirstSubmitDate': '2007-02-05', 'studyFirstSubmitQcDate': '2007-02-05', 'lastUpdatePostDateStruct': {'date': '2007-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary atherosclerosis, Spiral Computed Tomography'], 'conditions': ['Coronary Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '18652943', 'type': 'DERIVED', 'citation': 'Choi EK, Choi SI, Rivera JJ, Nasir K, Chang SA, Chun EJ, Kim HK, Choi DJ, Blumenthal RS, Chang HJ. Coronary computed tomography angiography as a screening tool for the detection of occult coronary artery disease in asymptomatic individuals. J Am Coll Cardiol. 2008 Jul 29;52(5):357-65. doi: 10.1016/j.jacc.2008.02.086.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted tomography as a screening tool in asymptomatic population.', 'detailedDescription': 'A large proportion of patients with sudden cardiac death or nonfatal myocardial infarction (MI) had no prior symptom, which emphasizes the importance of early detection and treatment of the underlying subclinical coronary atherosclerosis before they happen. However, there are no powerful screening methods to detect subclinical coronary atherosclerosis until recently. Traditional CAD risk factors, treadmill exercise test, and EBCT are known to have limited power to detect subclinical coronary atherosclerosis and predict future cardiac events.\n\nCoronary CT angiography (CTA) depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population. Instead of the probability of significant stenosis, CTA could provide information about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy.\n\nIn this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CTA and its impact on the management in asymptomatic population. And then, we will develop standardized protocol for the management of subclinical coronary atherosclerosis, and follow for adverse cardiac events.\n\nIn phase I study, we will enroll subjects who had undergone CTA and analyze the characteristics of plaques on CTA. Also, we will evaluate the impact of CTA by comparing the performance of secondary test with those who had not undergone CTA evaluation.\n\nIn phase II study, we will recruit subjects who had significant coronary stenosis on CTA. If the patients had significant stenosis, they will undergo coronary angiography to confirm the severity of stenosis. If they had coronary artery stenosis more than 75%, they will receive percutaneous coronary intervention with drug-eluting stent (DES). If they had intermediate lesion, their treatment option will be judged by the results of fractional flow reserve test. If they had coronary lesion less than 50%, they will be treated only by medication.\n\nWhen the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed.\n\nFollowing above treatment guidelines, all patients will be followed for adverse cardiac events for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asymptomatic subjects\n* 20-75 years\n* subjects who had undergone spiral coronary CT angiography for health check-up\n\nExclusion Criteria:\n\n* typical or atypical chest pain\n* serious comorbid conditions(i.e. malignancy)'}, 'identificationModule': {'nctId': 'NCT00431860', 'briefTitle': 'Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)', 'orgStudyIdInfo': {'id': 'B-0606/034-019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coronary computed tomographic angiography', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sungnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Huk-Jae Chang, MD, PhD', 'role': 'CONTACT', 'email': 'hjchang@snubh.org', 'phone': '82-32-787-7024'}], 'facility': 'Seoul National University Bundang hospital'}], 'centralContacts': [{'name': 'Huk-Jae Chang, MD, PhD', 'role': 'CONTACT', 'email': 'hjchang@snu.ac.kr', 'phone': '82-31-787-7024'}], 'overallOfficials': [{'name': 'Huk-Jae Chang, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}}}}